Free tool

FDA clearance lookup for at-home laser hair devices

Search every FDA 510(k) clearance record filed under product code OAP, the FDA classification for hair-growth laser devices such as caps, helmets and combs. Enter a K-number, a company or a device name.

Snapshot of 16 September 2026: 112 clearance records from 18 January 2007 to 17 July 2026, filed by 59 applicants.

Showing all 112 records, newest decision first.

  1. K261675 on the FDA 510(k) database (opens in a new tab)

    CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)

    Applicant
    Shenzhen Chuanghong Zhilian Technology Co., Ltd.
    Decision date
    17 July 2026
    Received
    21 May 2026
    Type
    Traditional 510(k)
  2. K261253 on the FDA 510(k) database (opens in a new tab)

    Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)

    Applicant
    Shown on the FDA record
    Decision date
    26 June 2026
    Received
    16 April 2026
    Type
    Traditional 510(k)
  3. K260899 on the FDA 510(k) database (opens in a new tab)

    Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)

    Applicant
    Zdeer Technology (Henan) Co., Ltd.
    Decision date
    16 June 2026
    Received
    18 March 2026
    Type
    Traditional 510(k)
  4. K253231 on the FDA 510(k) database (opens in a new tab)

    Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)

    Applicant
    Shown on the FDA record
    Decision date
    16 June 2026
    Received
    29 September 2025
    Type
    Traditional 510(k)
  5. K251684 on the FDA 510(k) database (opens in a new tab)

    Alma TED+ System

    Applicant
    Alma Lasers, Inc.
    Decision date
    5 June 2026
    Received
    2 June 2025
    Type
    Traditional 510(k)
  6. K253669 on the FDA 510(k) database (opens in a new tab)

    TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Decision date
    23 January 2026
    Received
    21 November 2025
    Type
    Traditional 510(k)
  7. K253349 on the FDA 510(k) database (opens in a new tab)

    Hair Regrowth Cap (Model: T-119-HRC)

    Applicant
    Light Tree Ventures Europe B.V.
    Decision date
    24 December 2025
    Received
    30 September 2025
    Type
    Traditional 510(k)
  8. K252414 on the FDA 510(k) database (opens in a new tab)

    Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Decision date
    30 October 2025
    Received
    1 August 2025
    Type
    Traditional 510(k)
  9. K252325 on the FDA 510(k) database (opens in a new tab)

    Hair Growth Laser Cap

    Applicant
    Cosmo Far East Technology Limited
    Decision date
    22 October 2025
    Received
    25 July 2025
    Type
    Traditional 510(k)
  10. K251017 on the FDA 510(k) database (opens in a new tab)

    CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)

    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Decision date
    17 June 2025
    Received
    2 April 2025
    Type
    Traditional 510(k)
  11. K250467 on the FDA 510(k) database (opens in a new tab)

    Red Light Hair Growth Cap (LP-RJVGRW-BLK)

    Applicant
    Shenzhen Idea Light Limited
    Decision date
    5 June 2025
    Received
    18 February 2025
    Type
    Traditional 510(k)
  12. K250308 on the FDA 510(k) database (opens in a new tab)

    Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)

    Applicant
    Dongguan Boyuan Intelligent Technology Co.,Ltd
    Decision date
    29 April 2025
    Received
    3 February 2025
    Type
    Traditional 510(k)
  13. K242747 on the FDA 510(k) database (opens in a new tab)

    FAQ™ (302)

    Applicant
    Foreo, Inc.
    Decision date
    11 December 2024
    Received
    12 September 2024
    Type
    Traditional 510(k)
  14. K242619 on the FDA 510(k) database (opens in a new tab)

    GroWell BT Hair Growth System (GW10042)

    Applicant
    Apira Science, Inc.
    Decision date
    2 December 2024
    Received
    3 September 2024
    Type
    Traditional 510(k)
  15. K242363 on the FDA 510(k) database (opens in a new tab)

    HIGHERDOSE Red Light Hat (HG-120K)

    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Decision date
    20 November 2024
    Received
    9 August 2024
    Type
    Traditional 510(k)
  16. K241342 on the FDA 510(k) database (opens in a new tab)

    Hair Growth Comb (SZ-23,SZ-23A)

    Applicant
    Shenzhen Nuon Medical Equipment Co., Ltd.
    Decision date
    8 November 2024
    Received
    13 May 2024
    Type
    Traditional 510(k)
  17. K242620 on the FDA 510(k) database (opens in a new tab)

    Breo Laser Hair Growth Comb (Scalp 3L)

    Applicant
    Shenzhen Breo Technology Co., Ltd.
    Decision date
    1 November 2024
    Received
    3 September 2024
    Type
    Traditional 510(k)
  18. K240472 on the FDA 510(k) database (opens in a new tab)

    PBM Hair Therapy Cap

    Applicant
    Dongguan Tutamen Metalwork Co., Ltd.
    Decision date
    11 October 2024
    Received
    20 February 2024
    Type
    Traditional 510(k)
  19. K240689 on the FDA 510(k) database (opens in a new tab)

    Robin's Egg

    Applicant
    Telebrands Corporation
    Decision date
    17 September 2024
    Received
    13 March 2024
    Type
    Traditional 510(k)
  20. K242441 on the FDA 510(k) database (opens in a new tab)

    Revian Lyte (10011)

    Applicant
    Revian, Inc.
    Decision date
    13 September 2024
    Received
    16 August 2024
    Type
    Special 510(k)
  21. K240456 on the FDA 510(k) database (opens in a new tab)

    Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

    Applicant
    Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
    Decision date
    22 May 2024
    Received
    15 February 2024
    Type
    Special 510(k)
  22. K240064 on the FDA 510(k) database (opens in a new tab)

    Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom

    Applicant
    Wontech Co., Ltd.
    Decision date
    7 February 2024
    Received
    9 January 2024
    Type
    Special 510(k)
  23. K232356 on the FDA 510(k) database (opens in a new tab)

    Laser Cap, Model: Hat-01

    Applicant
    Shown on the FDA record
    Decision date
    24 October 2023
    Received
    7 August 2023
    Type
    Traditional 510(k)
  24. K231321 on the FDA 510(k) database (opens in a new tab)

    Nooance Led And Laser Helmet

    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Decision date
    31 July 2023
    Received
    8 May 2023
    Type
    Traditional 510(k)
  25. K231153 on the FDA 510(k) database (opens in a new tab)

    Neuhat Hair Growth System; ibeauty.com Laser Cap

    Applicant
    Nature, Inc.redible, Inc.
    Decision date
    23 June 2023
    Received
    24 April 2023
    Type
    Traditional 510(k)
  26. K222790 on the FDA 510(k) database (opens in a new tab)

    F65 Laser System

    Applicant
    Lumenis Be, Ltd.
    Decision date
    14 June 2023
    Received
    15 September 2022
    Type
    Traditional 510(k)
  27. K230134 on the FDA 510(k) database (opens in a new tab)

    Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

    Applicant
    Shown on the FDA record
    Decision date
    23 May 2023
    Received
    17 January 2023
    Type
    Traditional 510(k)
  28. K230597 on the FDA 510(k) database (opens in a new tab)

    Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)

    Applicant
    Light Tree Ventures Europe B.V.
    Decision date
    28 April 2023
    Received
    3 March 2023
    Type
    Traditional 510(k)
  29. K223862 on the FDA 510(k) database (opens in a new tab)

    Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp

    Applicant
    Wontech Co., Ltd.
    Decision date
    28 April 2023
    Received
    23 December 2022
    Type
    Special 510(k)
  30. K230336 on the FDA 510(k) database (opens in a new tab)

    CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

    Applicant
    Light Tree Ventures Europe B.V.
    Decision date
    5 April 2023
    Received
    7 February 2023
    Type
    Traditional 510(k)
  31. K222477 on the FDA 510(k) database (opens in a new tab)

    Hair Growth Device

    Applicant
    Dongguan Lescolton Medical Equipment Co., Ltd.
    Decision date
    18 November 2022
    Received
    16 August 2022
    Type
    Traditional 510(k)
  32. K222364 on the FDA 510(k) database (opens in a new tab)

    Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)

    Applicant
    Xtrallux, LLC
    Decision date
    16 November 2022
    Received
    4 August 2022
    Type
    Traditional 510(k)
  33. K222081 on the FDA 510(k) database (opens in a new tab)

    ID-510 iRestore Elite

    Applicant
    Freedom Laser Therapy, Inc.
    Decision date
    13 October 2022
    Received
    15 July 2022
    Type
    Traditional 510(k)
  34. K213789 on the FDA 510(k) database (opens in a new tab)

    Intelligence LaserComb

    Applicant
    Yibin Yingtong Intelligent Technology Co., Ltd.
    Decision date
    24 June 2022
    Received
    6 December 2021
    Type
    Traditional 510(k)
  35. K213027 on the FDA 510(k) database (opens in a new tab)

    Laser Hair Growth Comb

    Applicant
    Kam Yuen Plastic Products , Ltd.
    Decision date
    26 May 2022
    Received
    21 September 2021
    Type
    Traditional 510(k)
  36. K213025 on the FDA 510(k) database (opens in a new tab)

    Laser hair growth helmet

    Applicant
    Kam Yuen Plastic Products , Ltd.
    Decision date
    12 May 2022
    Received
    21 September 2021
    Type
    Traditional 510(k)
  37. K220543 on the FDA 510(k) database (opens in a new tab)

    Auxo A300, A150 and APod

    Applicant
    Auxo Hair, LLC
    Decision date
    20 April 2022
    Received
    25 February 2022
    Type
    Traditional 510(k)
  38. K213447 on the FDA 510(k) database (opens in a new tab)

    LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.

    Applicant
    Shenzhen Cosbeauty Technology Co., Ltd.
    Decision date
    19 January 2022
    Received
    25 October 2021
    Type
    Traditional 510(k)
  39. K213094 on the FDA 510(k) database (opens in a new tab)

    ID-500 iRestore Hair Growth System

    Applicant
    Freedom Laser Therapy, Inc.
    Decision date
    22 December 2021
    Received
    24 September 2021
    Type
    Traditional 510(k)
  40. K211192 on the FDA 510(k) database (opens in a new tab)

    Grivamax Family of Lasers, Models 272 and 148

    Applicant
    Leana Orders, Inc.
    Decision date
    20 July 2021
    Received
    21 April 2021
    Type
    Traditional 510(k)
  41. K211038 on the FDA 510(k) database (opens in a new tab)

    Biophotas Celluma RESTORE

    Applicant
    Biophotas, Inc.
    Decision date
    29 June 2021
    Received
    7 April 2021
    Type
    Traditional 510(k)
  42. K210169 on the FDA 510(k) database (opens in a new tab)

    Hair Growth Device

    Applicant
    Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.
    Decision date
    16 April 2021
    Received
    22 January 2021
    Type
    Traditional 510(k)
  43. K203826 on the FDA 510(k) database (opens in a new tab)

    LaserCap Family of Lasers 300, 224, 120 & 80

    Applicant
    Transdermal Cap, Inc.
    Decision date
    29 March 2021
    Received
    29 December 2020
    Type
    Traditional 510(k)
  44. K202983 on the FDA 510(k) database (opens in a new tab)

    easy Hairfull

    Applicant
    Y & J Bio Co., Ltd.
    Decision date
    8 December 2020
    Received
    30 September 2020
    Type
    Traditional 510(k)
  45. K202631 on the FDA 510(k) database (opens in a new tab)

    iHelmet Laser Comb

    Applicant
    Slinph Technologies Co., Ltd.
    Decision date
    8 December 2020
    Received
    11 September 2020
    Type
    Traditional 510(k)
  46. K193008 on the FDA 510(k) database (opens in a new tab)

    Tricoglam Home Use

    Applicant
    Advihair S.R.L.
    Decision date
    3 December 2020
    Received
    28 October 2019
    Type
    Traditional 510(k)
  47. K201854 on the FDA 510(k) database (opens in a new tab)

    CAPOGEN Laser Cap

    Applicant
    Nature, Inc.redible, Inc.
    Decision date
    1 September 2020
    Received
    6 July 2020
    Type
    Traditional 510(k)
  48. K200464 on the FDA 510(k) database (opens in a new tab)

    LG Pra. L Derma LD Scalp Care

    Applicant
    Lg Electronics.Inc
    Decision date
    23 July 2020
    Received
    26 February 2020
    Type
    Traditional 510(k)
  49. K200929 on the FDA 510(k) database (opens in a new tab)

    Hair Growth System

    Applicant
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Decision date
    3 June 2020
    Received
    7 April 2020
    Type
    Traditional 510(k)
  50. K192552 on the FDA 510(k) database (opens in a new tab)

    Irradiation Cosmetic Device

    Applicant
    Chongqing Peninsula Medical Technology Co., Ltd.
    Decision date
    17 April 2020
    Received
    17 September 2019
    Type
    Traditional 510(k)
  51. K193667 on the FDA 510(k) database (opens in a new tab)

    Shapiro MD model laser 272

    Applicant
    Conversion Labs, Pr, LLC
    Decision date
    25 March 2020
    Received
    31 December 2019
    Type
    Traditional 510(k)
  52. K192585 on the FDA 510(k) database (opens in a new tab)

    Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

    Applicant
    Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
    Decision date
    29 January 2020
    Received
    19 September 2019
    Type
    Special 510(k)
  53. K190467 on the FDA 510(k) database (opens in a new tab)

    iHelmet Hair Growth System

    Applicant
    Slinph Technologies Co., Ltd.
    Decision date
    26 December 2019
    Received
    26 February 2019
    Type
    Traditional 510(k)
  54. K192627 on the FDA 510(k) database (opens in a new tab)

    Laser Hair Growth Cap

    Applicant
    Shang FA Biotechnology Co.
    Decision date
    13 December 2019
    Received
    23 September 2019
    Type
    Traditional 510(k)
  55. K191754 on the FDA 510(k) database (opens in a new tab)

    Hair Growth System

    Applicant
    Kunshan Bella Optical Technology Co., Ltd.
    Decision date
    22 November 2019
    Received
    1 July 2019
    Type
    Traditional 510(k)
  56. K192425 on the FDA 510(k) database (opens in a new tab)

    Hair Boom 69, Hair Boom Air, Ulike Hair UpUp

    Applicant
    Wontech Co., Ltd.
    Decision date
    30 September 2019
    Received
    5 September 2019
    Type
    Special 510(k)
  57. K192012 on the FDA 510(k) database (opens in a new tab)

    Capillus 112, Capillus 244

    Applicant
    Capillus
    Decision date
    12 September 2019
    Received
    29 July 2019
    Type
    Special 510(k)
  58. K191154 on the FDA 510(k) database (opens in a new tab)

    Hair Boom 69

    Applicant
    Wontech
    Decision date
    29 July 2019
    Received
    1 May 2019
    Type
    Traditional 510(k)
  59. K190685 on the FDA 510(k) database (opens in a new tab)

    Hair Growth System

    Applicant
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Decision date
    26 July 2019
    Received
    18 March 2019
    Type
    Traditional 510(k)
  60. K183417 on the FDA 510(k) database (opens in a new tab)

    iRestore Professional 282

    Applicant
    Freedom Laser Therapy, Inc.
    Decision date
    17 May 2019
    Received
    10 December 2018
    Type
    Traditional 510(k)
  61. K183329 on the FDA 510(k) database (opens in a new tab)

    Laser Hair Therapy

    Applicant
    Omm Imports, Inc. D/B/A Zero Gravity
    Decision date
    16 January 2019
    Received
    30 November 2018
    Type
    Traditional 510(k)
  62. K182562 on the FDA 510(k) database (opens in a new tab)

    Hair Boom 69

    Applicant
    Wontech
    Decision date
    16 November 2018
    Received
    18 September 2018
    Type
    Traditional 510(k)
  63. K182501 on the FDA 510(k) database (opens in a new tab)

    Hair Laser Headband

    Applicant
    Pulsaderm, LLC
    Decision date
    26 October 2018
    Received
    12 September 2018
    Type
    Special 510(k)
  64. K181878 on the FDA 510(k) database (opens in a new tab)

    Kiierr 272 Laser, Kiierr 148 Laser

    Applicant
    Kiierr International, LLC
    Decision date
    5 September 2018
    Received
    13 July 2018
    Type
    Traditional 510(k)
  65. K181308 on the FDA 510(k) database (opens in a new tab)

    SuperGrow 272, Ultimate 272

    Applicant
    Super Grow Lasers
    Decision date
    15 August 2018
    Received
    17 May 2018
    Type
    Traditional 510(k)
  66. K181253 on the FDA 510(k) database (opens in a new tab)

    Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup

    Applicant
    Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
    Decision date
    10 August 2018
    Received
    11 May 2018
    Type
    Traditional 510(k)
  67. K180885 on the FDA 510(k) database (opens in a new tab)

    HairMax Laser

    Applicant
    Lexington International, LLC
    Decision date
    20 June 2018
    Received
    4 April 2018
    Type
    Traditional 510(k)
  68. K180617 on the FDA 510(k) database (opens in a new tab)

    Hair Up

    Applicant
    Y & J Bio Co., Ltd.
    Decision date
    1 June 2018
    Received
    8 March 2018
    Type
    Traditional 510(k)
  69. K180460 on the FDA 510(k) database (opens in a new tab)

    Theradome LH40

    Applicant
    Theradome, Inc.
    Decision date
    18 May 2018
    Received
    20 February 2018
    Type
    Traditional 510(k)
  70. K173846 on the FDA 510(k) database (opens in a new tab)

    DermaScalp Laser Cap

    Applicant
    Dermascalp, LLC
    Decision date
    21 March 2018
    Received
    19 December 2017
    Type
    Traditional 510(k)
  71. K173729 on the FDA 510(k) database (opens in a new tab)

    REVIAN RED

    Applicant
    Photonmd, Inc.
    Decision date
    28 February 2018
    Received
    6 December 2017
    Type
    Traditional 510(k)
  72. K173678 on the FDA 510(k) database (opens in a new tab)

    Diode Laser Cap

    Applicant
    Cosmo Far East Technology Limited
    Decision date
    28 February 2018
    Received
    30 November 2017
    Type
    Traditional 510(k)
  73. K171835 on the FDA 510(k) database (opens in a new tab)

    Irradiation Aesthetic Device

    Applicant
    Chongqing Peninsula Medical Technology Co., Ltd.
    Decision date
    30 January 2018
    Received
    20 June 2017
    Type
    Traditional 510(k)
  74. K173843 on the FDA 510(k) database (opens in a new tab)

    illumiflow 148 Laser Cap

    Applicant
    Eglobal, LLC
    Decision date
    26 January 2018
    Received
    18 December 2017
    Type
    Special 510(k)
  75. K171775 on the FDA 510(k) database (opens in a new tab)

    Theradome LH80 PRO

    Applicant
    Theradome, Inc.
    Decision date
    9 January 2018
    Received
    14 June 2017
    Type
    Traditional 510(k)
  76. K172968 on the FDA 510(k) database (opens in a new tab)

    Hair Up

    Applicant
    Y & J Bio Co., Ltd.
    Decision date
    5 January 2018
    Received
    26 September 2017
    Type
    Traditional 510(k)
  77. K172982 on the FDA 510(k) database (opens in a new tab)

    SuperGrow 272, Ultimate 272

    Applicant
    Super Grow Lasers
    Decision date
    19 December 2017
    Received
    27 September 2017
    Type
    Traditional 510(k)
  78. K171895 on the FDA 510(k) database (opens in a new tab)

    Grivamax Hair Growth System

    Applicant
    Leana Orders, Inc.
    Decision date
    22 August 2017
    Received
    26 June 2017
    Type
    Traditional 510(k)
  79. K162782 on the FDA 510(k) database (opens in a new tab)

    iHelmet Hair Growth System

    Applicant
    Slinph Technologies Co., Ltd.
    Decision date
    4 April 2017
    Received
    3 October 2016
    Type
    Traditional 510(k)
  80. K162071 on the FDA 510(k) database (opens in a new tab)

    IllumiFlow Laser Cap

    Applicant
    Eglobal, LLC
    Decision date
    24 February 2017
    Received
    27 July 2016
    Type
    Traditional 510(k)
  81. K163170 on the FDA 510(k) database (opens in a new tab)

    Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352

    Applicant
    Capillus, LLC
    Decision date
    31 January 2017
    Received
    14 November 2016
    Type
    Traditional 510(k)
  82. K162994 on the FDA 510(k) database (opens in a new tab)

    Capillus302, Capillus312, Capillus352

    Applicant
    Capillus, LLC
    Decision date
    18 November 2016
    Received
    27 October 2016
    Type
    Special 510(k)
  83. K161875 on the FDA 510(k) database (opens in a new tab)

    LaserCap300, LaserCap224, LaserCap120, LaserCap80

    Applicant
    Transdermal Cap, Inc.
    Decision date
    30 September 2016
    Received
    8 July 2016
    Type
    Traditional 510(k)
  84. K160728 on the FDA 510(k) database (opens in a new tab)

    NutraStim Hair Laser Helmet

    Applicant
    Nutra Luxe MD, LLC
    Decision date
    16 September 2016
    Received
    16 March 2016
    Type
    Traditional 510(k)
  85. K161046 on the FDA 510(k) database (opens in a new tab)

    Laser Helmet LH40-EVO

    Applicant
    Theradome, Inc.
    Decision date
    12 May 2016
    Received
    13 April 2016
    Type
    Special 510(k)
  86. K160285 on the FDA 510(k) database (opens in a new tab)

    Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202

    Applicant
    Capillus, LLC
    Decision date
    25 April 2016
    Received
    3 February 2016
    Type
    Traditional 510(k)
  87. K152587 on the FDA 510(k) database (opens in a new tab)

    DermaScalp Laser Cap

    Applicant
    Dermascalp, LLC
    Decision date
    4 February 2016
    Received
    10 September 2015
    Type
    Traditional 510(k)
  88. K153618 on the FDA 510(k) database (opens in a new tab)

    Capillus202

    Applicant
    Capillus, LLC
    Decision date
    19 January 2016
    Received
    18 December 2015
    Type
    Special 510(k)
  89. K151662 on the FDA 510(k) database (opens in a new tab)

    iRestore

    Applicant
    Freedom Laser Therapy, Inc.
    Decision date
    6 January 2016
    Received
    19 June 2015
    Type
    Traditional 510(k)
  90. K152019 on the FDA 510(k) database (opens in a new tab)

    HairMD

    Applicant
    Trophy Skin, Inc.
    Decision date
    16 November 2015
    Received
    21 July 2015
    Type
    Traditional 510(k)
  91. K151516 on the FDA 510(k) database (opens in a new tab)

    Capillus82

    Applicant
    Capillus, LLC
    Decision date
    21 August 2015
    Received
    5 June 2015
    Type
    Special 510(k)
  92. K150613 on the FDA 510(k) database (opens in a new tab)

    LaserCap LC Pro and LC Elite

    Applicant
    Transdermal Cap, Inc.
    Decision date
    22 July 2015
    Received
    10 March 2015
    Type
    Traditional 510(k)
  93. K150578 on the FDA 510(k) database (opens in a new tab)

    Capillus 272 Office Pro

    Applicant
    Capillus, LLC
    Decision date
    9 June 2015
    Received
    9 March 2015
    Type
    Traditional 510(k)
  94. K142824 on the FDA 510(k) database (opens in a new tab)

    LX-100 Hair Growth Stimulation System

    Applicant
    Hairlabs International, Inc.
    Decision date
    14 April 2015
    Received
    30 September 2014
    Type
    Traditional 510(k)
  95. K143199 on the FDA 510(k) database (opens in a new tab)

    Capillus 272 Pro

    Applicant
    Capillus, LLC
    Decision date
    29 January 2015
    Received
    6 November 2014
    Type
    Traditional 510(k)
  96. K141596 on the FDA 510(k) database (opens in a new tab)

    NUTRA STIM HAIR LASER COMB

    Applicant
    Nutra Luxe MD, LLC
    Decision date
    8 January 2015
    Received
    13 June 2014
    Type
    Traditional 510(k)
  97. K141588 on the FDA 510(k) database (opens in a new tab)

    NUTRA STIM HAIR LASER COMB

    Applicant
    Nutra Luxe MD, LLC
    Decision date
    8 January 2015
    Received
    13 June 2014
    Type
    Traditional 510(k)
  98. K140931 on the FDA 510(k) database (opens in a new tab)

    IGROW II HAIR GROWTH SYSTEM

    Applicant
    Apira Science, Inc.
    Decision date
    5 December 2014
    Received
    11 April 2014
    Type
    Traditional 510(k)
  99. K142573 on the FDA 510(k) database (opens in a new tab)

    HairMax LaserComb, HairMax LaserComb

    Applicant
    Lexington International, LLC
    Decision date
    1 December 2014
    Received
    12 September 2014
    Type
    Traditional 510(k)
  100. K141567 on the FDA 510(k) database (opens in a new tab)

    IGROW - II HAIR GROWTH SYSTEM, IGROW HAIR GROWTH SYSTEM

    Applicant
    Apira Science, Inc.
    Decision date
    21 August 2014
    Received
    12 June 2014
    Type
    Traditional 510(k)
  101. K132646 on the FDA 510(k) database (opens in a new tab)

    SUNETICS CLINICAL BIO-STIMULATION LASER

    Applicant
    Sunetics International Marketing Group, LLC
    Decision date
    20 December 2013
    Received
    26 August 2013
    Type
    Traditional 510(k)
  102. K121920 on the FDA 510(k) database (opens in a new tab)

    LASERBRUSH

    Applicant
    Sunetics International Marketing Group, LLC
    Decision date
    27 June 2013
    Received
    2 July 2012
    Type
    Traditional 510(k)
  103. K122950 on the FDA 510(k) database (opens in a new tab)

    LASER HELMET

    Applicant
    Theradome, Inc.
    Decision date
    14 June 2013
    Received
    25 September 2012
    Type
    Traditional 510(k)
  104. K122248 on the FDA 510(k) database (opens in a new tab)

    IGROW II HAIR GROWTH SYSTEM

    Applicant
    Apira Science, Inc.
    Decision date
    5 December 2012
    Received
    27 July 2012
    Type
    Traditional 510(k)
  105. K113097 on the FDA 510(k) database (opens in a new tab)

    LASER HELMET

    Applicant
    Theradome, Inc.
    Decision date
    2 March 2012
    Received
    19 October 2011
    Type
    Traditional 510(k)
  106. K112524 on the FDA 510(k) database (opens in a new tab)

    HAIRMAX LASERCOMB

    Applicant
    Lexington International, LLC
    Decision date
    26 September 2011
    Received
    31 August 2011
    Type
    Special 510(k)
  107. K111714 on the FDA 510(k) database (opens in a new tab)

    HAIRMAX DUAL 12

    Applicant
    Lexington International, LLC
    Decision date
    16 August 2011
    Received
    20 June 2011
    Type
    Traditional 510(k)
  108. K110233 on the FDA 510(k) database (opens in a new tab)

    HAIRMAX LASERCOMB

    Applicant
    Lexington International, LLC
    Decision date
    27 May 2011
    Received
    26 January 2011
    Type
    Traditional 510(k)
  109. K103368 on the FDA 510(k) database (opens in a new tab)

    HAIRMAX LASERCOMB

    Applicant
    Lexington International, LLC
    Decision date
    6 April 2011
    Received
    17 November 2010
    Type
    Traditional 510(k)
  110. K091496 on the FDA 510(k) database (opens in a new tab)

    MEP-90 HAIR GROWTH STIMULATION SYSTEM

    Applicant
    Midwest Rf, LLC
    Decision date
    23 February 2010
    Received
    20 May 2009
    Type
    Traditional 510(k)
  111. K093499 on the FDA 510(k) database (opens in a new tab)

    HAIRMAX LASERCOMB

    Applicant
    Lexington International, LLC
    Decision date
    23 November 2009
    Received
    12 November 2009
    Type
    Special 510(k)
  112. K060305 on the FDA 510(k) database (opens in a new tab)

    HAIRMAX LASERCOMB

    Applicant
    Lexington International, LLC
    Decision date
    18 January 2007
    Received
    6 February 2006
    Type
    Traditional 510(k)

How to check any laser cap in 60 seconds

  1. Find the K-number. It is a letter K followed by six digits. Look on the label, the box, the manual or the product listing. If it is not printed anywhere, ask the seller for it.
  2. Paste it in. Put the K-number in the search box above, or into FDA’s 510(k) database (opens in a new tab).
  3. Compare the record with the product. Check the applicant (the company that filed) and the device name or model codes against what you are buying. Clearances are often held by the original manufacturer under a different name from the brand on the box, so a different applicant name is normal; a matching model name is the stronger link.
  4. Open the 510(k) summary. The FDA record links a summary document that lists the models covered, the specifications and the indication for use.

One clearance can cover a family of models, and a record count is not a device count. FDA 510(k) clearance is a finding of substantial equivalence to an earlier device, not a rating of quality or effectiveness. What “FDA 510(k) cleared” means →

About this data

  • Source. openFDA device 510(k) endpoint, product code OAP (“Laser, Comb, Hair”, 21 CFR 890.5500), frozen in a snapshot dated 16 September 2026. This page is an independent copy of public FDA records, not an FDA service. Confirm any record on FDA’s own page, linked from each row.
  • Applicant is the company that filed the 510(k), which is often a manufacturer rather than the brand on the box. For a few records the applicant name is not reproduced on this page; open the FDA record to see it. Applicant location is not shown.
  • Cite the dataset. Onwuamaegbu, D. (2026). Product code OAP device records: frozen openFDA 510(k), openFDA UDI and AccessGUDID history extracts with reproducible figures (v1.0) [Data set]. Zenodo. https://doi.org/10.5281/zenodo.23103200
  • Method and limits. Read the full transparency report → The record tables are also available as CSV and JSON (CC BY 4.0).
  • Corrections. Spot an error? Email corrections@luxuel.com.

Published by Luxuel, which sells an FDA 510(k)-cleared laser cap (K261253). See the Laser Cap 272.