510(k) K254271 ยท GEX Powered Laser Surgical Instrument
CAPRI
| Applicant | ORO Co., Ltd., Gimpo-Si, KR |
| Decision | Substantially Equivalent, Feb 26, 2026 |
| Received | Dec 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254271
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.