Data / Medical devices / Spain / Leaseir Technologies Slu
Leaseir Technologies Slu: FDA-registered device maker in Gijon Asturias(Autonomous Community), Spain, 2 510(k) clearances
Leaseir Technologies Slu is registered with the FDA (registration 3023344928) in Gijon Asturias(Autonomous Community), Spain. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 4, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023344928
- Address
- Jimena Fernandez de la Vega 140 1H, Gijon Asturias(Autonomous Community), Spain, 33203
- Owner or operator
- Leaseir Technologies SLU (10085381)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 11, 2022
- Registered through
- 2026
- Brand names listed
- Leaseir MHR Xcell, Leaseir MHR Xcell Dual Blend and Quad Blend handpieces
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2026 | K253251 | Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) | GEX | Substantially Equivalent | Leaseir Technologies, Slu | accessdata.fda.gov |
| June 2, 2022 | K214049 | Leaseir MHR Xcell | GEX | Substantially Equivalent | Leaseir Technologies, Slu | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2025 | 98176 | Class II | Completed | 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 general and plastic surge | The console label for affected devices is missing the "DANGER" symbol. | accessdata.fda.gov |
Compare with other makers
Updated May 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.