510(k) K921995 ยท GEX Powered Laser Surgical Instrument
CANDELA H:ERB LASER
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Nov 7, 1994 |
| Received | Apr 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921995
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.