Data / Medical devices / Laser, Comb, Hair / United States
FDA-registered makers of Laser, Comb, Hair in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Laser, Comb, Hair (product code OAP). 10 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Laser, Comb, Hair
- Product code
- OAP
- Country
- United States
Makers of Laser, Comb, Hair in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Curallux, LLC | Miami, FL, United States | Complaint file establishment, Manufacturer | 7 | September 12, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hairmax International LLC | Boca Raton, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 6 | May 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Apira Science, Inc. | Albuquerque, NM, United States | Manufacturer | 4 | December 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| PJM Worldwide, LLC | Miami, FL, United States | Repackager or relabeler, Specification developer | 3 | May 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| REVIAN, Inc | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | September 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Theradome, Inc. | Wilmington, DE, United States | Specification developer | 2 | May 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Xtrallux, LLC | Miami, FL, United States | Complaint file establishment, Manufacturer | 2 | May 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Biophotas, Inc. | Tustin, CA, United States | Complaint file establishment, Manufacturer | 1 | June 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hair Laser Manufacturing, LLC | Southlake, TX, United States | Manufacturer | 1 | December 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| TRANSDERMAL CAP INC dba LaserCap Company | Highland Heights, OH, United States | Manufacturer | 1 | March 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Modulus Inc. | Milpitas, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.