510(k) K261570 ยท GEX Powered Laser Surgical Instrument
PICOSURE WORKSTATION
| Applicant | Cynosure, LLC, Wesford MA, US |
| Decision | Substantially Equivalent, Jun 17, 2026 |
| Received | May 12, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261570
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.