510(k) K193500 ยท GEX Powered Laser Surgical Instrument
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
| Applicant | Lumenis, Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jan 16, 2020 |
| Received | Dec 17, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193500
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.