Data / Medical devices / United States / Hair Laser Manufacturing, LLC
Hair Laser Manufacturing, LLC: FDA-registered device maker in Southlake, TX, United States, 1 510(k) clearance
Hair Laser Manufacturing, LLC is registered with the FDA (registration 3030265332) in Southlake, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030265332
- Address
- 1560 E Southlake Blvd Suite 100, Southlake, TX, United States, 76092
- Owner or operator
- Hair Laser Manuafacuring, LLC (10089783)
- Roles
- Manufacturer
- First device listed
- January 8, 2024
- Registered through
- 2026
- Brand names listed
- GetHairMD, Sunetics Clinical Hair Growth Laser
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Comb, Hair | OAP | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2013 | K132646 | SUNETICS CLINICAL BIO-STIMULATION LASER | OAP | Substantially Equivalent | Sunetics International Marketing Group, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Laser, Comb, Hair
- All makers of Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Updated December 20, 2013. 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.