510(k) K100228 ยท GEX Powered Laser Surgical Instrument
VERSAPULSE MODEL P20 LASER SYSTEM
| Applicant | Lumenis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 24, 2010 |
| Received | Jan 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100228
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.