510(k) K201111 ยท GEX Powered Laser Surgical Instrument
GentleMax Pro Plus
| Applicant | Candela Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, May 26, 2020 |
| Received | Apr 27, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201111
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.