510(k) K214049 · GEX Powered Laser Surgical Instrument
Leaseir MHR Xcell
| Applicant | Leaseir Technologies, Slu, Gijón, ES |
| Decision | Substantially Equivalent, Jun 2, 2022 |
| Received | Dec 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | LEASEIR TECHNOLOGIES SLU Brand Name: LEASEIR
Product Name: LEASEIR MHR XCELL
Model/Catalog Number: MHR 110-b
Software Version: 1.5.0.0
Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in gener Completed |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.