Data / Medical devices / United States / Ophthalmed LLC
Ophthalmed LLC: FDA-registered device maker in Roswell, GA, United States, 3 510(k) clearances
Ophthalmed LLC is registered with the FDA (registration 3004497289) in Roswell, GA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 25, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004497289
- Address
- 1050 Northfield Ct Ste 280, Roswell, GA, United States, 30076
- Owner or operator
- OPHTHALMED LLC (9051325)
- Roles
- Manufacturer
- First device listed
- December 23, 2005
- Registered through
- 2026
- Brand names listed
- A4xx010 (20g laser/asp probe), A5xxx0x (20g, 23g and 25g laser/illum probe), A6xxx10 (20g laser/illum/asp probe), A8xx000 (23g laser probe), A92x013 (23g laser/asp probe), Ax0x000 (bending laser probes, 20g/23g/25g), B62xx13 (23g laser/illum/asp probe), LF20 and A2xx000 (20g laser probe) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Photocoagulator And Accessories | HQB | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| June 25, 2015 | K142830 | Ophthalmed Bending Laser Probes | HQF | Substantially Equivalent | Ophthalmed, LLC | accessdata.fda.gov |
| September 21, 2005 | K050807 | 20G SMA LASER FIBER, MODEL LF100 | HQF | Substantially Equivalent | Ophthalmed, LLC | accessdata.fda.gov |
| August 20, 2002 | K021696 | 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 | GEX | Substantially Equivalent | Ophthalmed, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Laser, Ophthalmic
- All makers of Photocoagulator And Accessories
Updated June 25, 2015. 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.