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 six-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 16 rows: 14 competitor rows and two Luxuel rows. Luxuel's rows remain included in the dataset, and competitor denominators never include them.
Showing 16 of 16 rows
| Brand / model | Publishes 510(k) | Published number | In OAP snapshot | FDA applicant | FDA device name | Decision | Price | Availability | FDA record |
|---|---|---|---|---|---|---|---|---|---|
|
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 | 1799.0 | available | |
|
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 | |
|
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 | |
|
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 | |
|
Theradome Theradome PRO LH80 |
Yes | K122950 | Yes | Theradome, Inc. | LASER HELMET | 2013-06-14 | 995.0 | available | Open FDA record |
|
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 | preorder | 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. 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 Caps
132 or 272 × 650nm laser diodes · FDA 510(k) cleared (K261253) · $599 and $899 Founder Pricing
See the 272 →See the 132 →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 low-level laser therapy as a category and do not represent clinical testing of this specific product. Individual results vary and depend on consistent use over time. The FDA 510(k) clearance (K261253) is held by the manufacturer.
