Data / Medical devices / United States / OTC Partners, LLC
OTC Partners, LLC: FDA-registered device maker in Alpharetta, GA, United States, 1 510(k) clearance
OTC Partners, LLC is registered with the FDA (registration 3015529593) in Alpharetta, GA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 15, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015529593
- Address
- 5755 N Point Pkwy Ste 12, Alpharetta, GA, United States, 30022
- Owner or operator
- OTZ Partners LLC dba Remy Laser, LLC (10094566)
- Roles
- Complaint file establishment
- First device listed
- December 8, 2025
- Registered through
- 2026
- Brand names listed
- REMY Dual Wave Medical Diode Laser System, REMY Fx Quad Wave Medical Diode Laser System, REMY Single Wave Medical Diode Laser System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment | accessdata.fda.gov |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | 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 15, 2019 | K190034 | REMY Medical Therapy Laser System | PDZ | Substantially Equivalent | Footdocprenur, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Powered Laser Surgical Instrument
- All makers of Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Updated May 15, 2019. 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.