510(k) K100590 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
EDGE CO2 LASER SYSTEM
| Applicant | Jm System Co., Ltd., Geumchen-Gu, Seoul,, KR |
| Decision | Substantially Equivalent, Nov 10, 2010 |
| Received | Mar 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100590
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.