510(k) K882243 ยท GEX Powered Laser Surgical Instrument
SPTL-1 PULSED DYE LASER
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Jul 5, 1988 |
| Received | May 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882243
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.