510(k) K973354 ยท GEX Powered Laser Surgical Instrument
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
| Applicant | Sharplan Lasers, Inc., Warwick RI, US |
| Decision | Substantially Equivalent, Dec 4, 1997 |
| Received | Sep 5, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973354
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.