510(k) K913569 ยท GEX Powered Laser Surgical Instrument
COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
| Applicant | Hgm Medical Laser Systems, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 17, 1991 |
| Received | Aug 9, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913569
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2006 | Lumenis Inc. Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems;
Manufactured before November 4, 2003;
Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.