510(k) K193478 ยท GEX Powered Laser Surgical Instrument
XTRAC Momentum Excimer Laser System
| Applicant | Strata Skin Sciences, Inc., Horsham PA, US |
| Decision | Substantially Equivalent, Jan 14, 2020 |
| Received | Dec 16, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193478
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.