Leaseir Technologies, Slu

Medical device manufacturer in Gijon, ES.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece:…GEX · Traditional 05/04/2026SE
K214049Leaseir MHR XcellGEX · Traditional 06/02/2022SE

Recalls

RecallProductInitiated
Z-1130-2026 Class IIBrand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b…The console label for affected devices is missing the "DANGER" symbol. 12/15/2025Completed