510(k) K261221 · GEX Powered Laser Surgical Instrument
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
| Applicant | Olympus Surgical Technologies America, Westborough MA, US |
| Decision | Substantially Equivalent, Jul 24, 2026 |
| Received | Apr 14, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261221
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.