Data / Medical devices / United States / Hairmax International LLC
Hairmax International LLC: FDA-registered device maker in Boca Raton, FL, United States, 6 510(k) clearances
Hairmax International LLC is registered with the FDA (registration 3006182775) in Boca Raton, FL, United States. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated May 12, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006182775
- Address
- 1040 Holland DR, Boca Raton, FL, United States, 33487
- Owner or operator
- HAIRMAX INTERNATIONAL, LLC (9055586)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 21, 2013
- Registered through
- 2026
- Brand names listed
- Actonis 18 Dual Action, HairMax Laser 202, HairMax Laser 272, HairMax Laser 80, HairMax LaserBand 82, HairMax LaserComb Ultima 12, HairMax LaserComb Ultima 9, HairMax Professional 12 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 2022 | K213025 | Laser hair growth helmet | OAP | Substantially Equivalent | Kam Yuen Plastic Products , Ltd. | accessdata.fda.gov |
| June 20, 2018 | K180885 | HairMax Laser | OAP | Substantially Equivalent | Lexington International, LLC | accessdata.fda.gov |
| December 1, 2014 | K142573 | HairMax LaserComb, HairMax LaserComb | OAP | Substantially Equivalent | Lexington International, LLC | accessdata.fda.gov |
| August 16, 2011 | K111714 | HAIRMAX DUAL 12 | OAP | Substantially Equivalent | Lexington International, LLC | accessdata.fda.gov |
| May 27, 2011 | K110233 | HAIRMAX LASERCOMB | OAP | Substantially Equivalent | Lexington International, LLC | accessdata.fda.gov |
| April 6, 2011 | K103368 | HAIRMAX LASERCOMB | OAP | Substantially Equivalent | Lexington International, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 12, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.