510(k) K915651 ยท GEX Powered Laser Surgical Instrument
OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM
| Applicant | Summit Technology, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 15, 1992 |
| Received | Dec 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915651
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.