510(k) K183566 ยท GEX Powered Laser Surgical Instrument
CLARITY II Laser System
| Applicant | Lutronic Corporation, Deogyang-Gu, Goyang-Si, KR |
| Decision | Substantially Equivalent, Jun 14, 2019 |
| Received | Dec 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2026 | Lutronic Corporation CLARITY II Laser System; Model No. 1110200210. Open, Classified |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.