At-Home Laser Device 510(k) Lookup
The short version
- Search the audited brand and model rows below.
- A missing published number is a website disclosure finding, not evidence that a product lacks clearance.
- Applicant means the regulatory filer, not necessarily the consumer-facing brand.
This is the working lookup for the 2026 At-Home Laser Hair Device Transparency Report. It joins the 24-brand website audit to the frozen OAP 510(k) snapshot so a reader can see what each brand publishes, what the FDA record says, and where the two do or do not connect.
The table contains 48 rows: 46 competitor rows and two Luxuel rows. Luxuel's rows remain included in the dataset, and competitor denominators never include them.
22 September update: The Capillus PRO S2 row remains here as part of the frozen 16 September audit. Its former product page now redirects to the Capillus homepage and it was absent from the official product feed checked on 22 September. Its current price and availability are unverified, so it is omitted from the current laser-cap spec index.
Showing 48 of 48 rows
| Brand / model | Publishes 510(k) | Published number | In OAP snapshot | FDA applicant | FDA device name | Decision | Price | Availability | FDA record |
|---|---|---|---|---|---|---|---|---|---|
|
Bosley Bosley Revitalizer Flex 164 |
No | Not published | Not applicable | Not published | Not published | Not published | 699.0 | available | |
|
Bosley Bosley Revitalizer Flex 272 |
No | Not published | Not applicable | Not published | Not published | Not published | 1099.0 | available | |
|
Bosley Bosley Revitalizer Flex 96 |
No | Not published | Not applicable | Not published | Not published | Not published | 499.0 | sold_out | |
|
Capillus Capillus MD DUO |
No | Not published | Not applicable | Not published | Not published | Not published | 3699.0 | available | |
|
Capillus Capillus PRO |
No | Not published | Not applicable | Not published | Not published | Not published | 1699.0 | available | |
|
Capillus Capillus PRO S1 |
No | Not published | Not applicable | Not published | Not published | Not published | 2499.0 | sold_out | |
|
Capillus Capillus PRO S2 |
No | Not published | Not applicable | Not published | Not published | Not published | 16 Sep snapshot: $1,799; current price unverified | Current status unverified (22 Sep) | |
|
Capillus Capillus Spectrum |
No | Not published | Not applicable | Not published | Not published | Not published | 2699.0 | available | |
|
Capillus Capillus TriSpectrum |
No | Not published | Not applicable | Not published | Not published | Not published | 3299.0 | available | |
|
Capogen Capogen 148 Laser Cap |
No | Not published | Not applicable | Not published | Not published | Not published | 350.0 | sold_out | |
|
Capogen Capogen 272 Laser Cap |
No | Not published | Not applicable | Not published | Not published | Not published | 590.0 | sold_out | |
|
Celluma Celluma RESTORE |
No | Not published | Not applicable | Not published | Not published | Not published | 1195.0 | available | |
|
CurrentBody LED Red Light Hair Growth Helmet |
No | Not published | Not applicable | Not published | Not published | Not published | 859.99 | sold_out | |
|
FAQ Swiss FAQ™ 301 |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | available | |
|
FAQ Swiss FAQ™ 302 |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | available | |
|
GetHairMD Dual Wave Energy Cap |
No | Not published | Not applicable | Not published | Not published | Not published | 1500.0 | sold_out | |
|
GroWell GroWell Laser Hair Regrowth Cap – Red Light Therapy Device |
No | Not published | Not applicable | Not published | Not published | Not published | 549.99 | available | |
|
HairMax Actonis 18 Dual Action LaserComb |
No | Not published | Not applicable | Not published | Not published | Not published | 449.0 | available | |
|
HairMax PowerFlex 272 Laser Cap |
No | Not published | Not applicable | Not published | Not published | Not published | 1799.0 | available | |
|
Haloral 3-in-1 Microcurrent & LED Therapy Comb |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | available | |
|
Haloral Red Light Therapy Cap |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | available | |
|
KeraFactor KeraFlex Duo |
No | Not published | Not applicable | Not published | Not published | Not published | 2000.0 | available | |
|
KeraFactor KeraFlex Laser Cap |
No | Not published | Not applicable | Not published | Not published | Not published | 1399.0 | available | |
|
Kiierr Kiierr 148 Pro |
No | Not published | Not applicable | Not published | Not published | Not published | 799.0 | available | |
|
Kiierr Kiierr 272 Premier |
No | Not published | Not applicable | Not published | Not published | Not published | 1199.0 | available | |
|
Kiierr Kiierr 302 MD Ultra Flex |
No | Not published | Not applicable | Not published | Not published | Not published | 1799.0 | available | |
|
LESCOLTON LS-D601 |
No | Not published | Not applicable | Not published | Not published | Not published | 359.0 | sold_out | |
|
LESCOLTON LS-D620 |
No | Not published | Not applicable | Not published | Not published | Not published | 399.0 | sold_out | |
|
LESCOLTON LS-D630 |
No | Not published | Not applicable | Not published | Not published | Not published | 459.0 | sold_out | |
|
LaserCap LaserCap HD |
No | Not published | Not applicable | Not published | Not published | Not published | 2495.0 | available | |
|
LaserCap LaserCap HD+ |
No | Not published | Not applicable | Not published | Not published | Not published | 2995.0 | available | |
|
LaserCap LaserCap SD |
No | Not published | Not applicable | Not published | Not published | Not published | 995.0 | available | |
|
Qure Q-Renew LLLT Helmet |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | preorder | |
|
REVIAN REVIAN Lyte Hair Growth Device |
No | Not published | Not applicable | Not published | Not published | Not published | 1295.0 | available | |
|
REVIAN REVIAN Red Hair Growth System |
No | Not published | Not applicable | Not published | Not published | Not published | 1995.0 | available | |
|
Shapiro MD Laser Hair Cap |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | sold_out | |
|
Theradome Theradome PRO LH80 |
Yes | K122950 | Yes | Theradome, Inc. | LASER HELMET | 2013-06-14 | 995.0 | available | Open FDA record |
|
Xtrallux Xtrallux Alpha (136) Hair Regrowth Laser Cap |
Yes | K222364 | Yes | Xtrallux, LLC | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) | 2022-11-16 | 699.0 | available | Open FDA record |
|
Xtrallux Xtrallux SuperPlus (276) Hair Regrowth Laser Cap |
Yes | K222364 | Yes | Xtrallux, LLC | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) | 2022-11-16 | 1099.0 | available | Open FDA record |
|
Xtrallux Xtrallux TurboPro (316) Hair Regrowth Laser Cap |
Yes | K222364 | Yes | Xtrallux, LLC | Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) | 2022-11-16 | 1599.0 | available | Open FDA record |
|
Zero Gravity RECREO |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | available | |
|
breo Breo S3 Scalp Massager |
No | Not published | Not applicable | Not published | Not published | Not published | 199.99 | available | |
|
breo LumiHeal Pro Laser Scalp Massager |
No | Not published | Not applicable | Not published | Not published | Not published | 239.99 | available | |
|
iGrow iGrow Hair Growth System |
No | Not published | Not applicable | Not published | Not published | Not published | 695.0 | available | |
|
iRestore iRestore Professional 282 |
No | Not published | Not applicable | Not published | Not published | Not published | Not published | available | |
|
illumiflow illumiflow 272 Pro |
Yes | K162071 | Yes | Eglobal, LLC | IllumiFlow Laser Cap | 2017-02-24 | 899.0 | available | Open FDA record |
|
Luxuel Laser Cap 132 |
Yes | K261253 | Yes | Contract manufacturer — see FDA record | 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) | 2026-06-26 | 599.0 | sold_out | Open FDA record |
|
Luxuel Laser Cap 272 |
Yes | K261253 | Yes | Contract manufacturer — see FDA record | 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) | 2026-06-26 | 899.0 | available | Open FDA record |
How to read this table
“Publishes a number” means that a specific 510(k) number was findable on the brand's own website when checked. “In OAP snapshot” means the published number appears in the frozen openFDA product-code-OAP file. A blank FDA field is not a finding that the product is uncleared; it may use another product code or simply not publish a number on the audited pages.
The underlying report explains the method, limitations, conflict disclosure and correction process. If the regulatory terms are unfamiliar, read what FDA 510(k) cleared means → before interpreting a row. Each row links to the FDA record where a published number exists. If you spot an error, email corrections@luxuel.com with “transparency report” in the subject.
The Luxuel Laser Cap 272
272 × 650nm laser diodes · FDA 510(k) cleared (K261253) · $899
See the 272 →Written by Dominic Onwuamaegbu, founder of Luxuel.
He is not a clinician. These pages are written from published research and primary FDA records, with the sources linked so you can check them, and Luxuel sells the devices they describe. Corrections go to corrections@luxuel.com.
Not intended to diagnose, treat, cure, or prevent any disease. The clinical studies referenced evaluated a clinically studied 650nm wavelength and the low-level laser therapy category broadly. Individual results vary and depend on consistent use over time. The FDA 510(k) clearance (K261253) is held by the manufacturer.
