510(k) K232568 ยท GEX Powered Laser Surgical Instrument
IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
| Applicant | Ipg Medical Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Mar 21, 2024 |
| Received | Aug 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232568
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2026 | IPG Medical Corporation Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.