510(k) K253251 ยท GEX Powered Laser Surgical Instrument
Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)
| Applicant | Leaseir Technologies, Slu, Gijon, ES |
| Decision | Substantially Equivalent, May 4, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253251
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.