510(k) K100415 ยท GEX Powered Laser Surgical Instrument
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
| Applicant | Lumenis, Kfar Saba, IL |
| Decision | Substantially Equivalent, Apr 21, 2010 |
| Received | Feb 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100415
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2016 | Lumenis Limited FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590)
Provide fractional treatments in gynecology. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.