Leaseir Technologies, S.L.U.
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000002995
- Devices
- 4
- Registrations
- EUDAMED
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
What Leaseir Technologies, S.L.U. makes
Leaseir Technologies, S.L.U. manufactures diode laser systems designed for professional hair removal, including the MHR Laser System and MHR Xcell. These devices feature interchangeable handpieces with varying surface areas and deliver high-energy pulses for intensive use in clinical or aesthetic settings.
The company’s products fall under EU Class IIb medical device classification and are registered in the EUDAMED database. The manufacturer is based in Spain.
Catalogue
Leaseir MHR Xcell Ref K214049
Regimes: 510(k) Registry: 510(k)- Regimes: CE MDR 510(k) Registry: 510(k)
- Regimes: CE MDD Registry: EUDAMED
Leaseir MHR Xcell Ref MHR 110-b
Regimes: CE MDR Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- ES-MF-000002995
- EU VAT number
- B33987660
- EUDAMED status
- Active
- EUDAMED registered name
- LEASEIR TECHNOLOGIES, S.L.U.
- EUDAMED abbreviated name
- LEASEIR
- Registered address
- 140, Jimena Fernández de la Vega, 33203, Gijón, Spain
- Website
- technologies.leaseir.com/
- [email protected]
- Phone
- +34 984 39 09 33
- PRRC contact
- Rosario Boto Martínez
FDA recalls
FDA recall records list 1 recall initiated by LEASEIR TECHNOLOGIES, S.L.U., initiated on 2025-12-15. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 15 Dec 2025 Z-1130-2026 Class II Completed The console label for affected devices is missing the "DANGER" symbol.
From the company website
Leaseir MHR Laser System is a diode hair removal device with three different interchangeable head pieces of up to 3,7cm². A device for intensive use that can give 40 J/cm² at 4 Hz in 30 ms for hours .
Frequently asked questions
How many devices does LEASEIR TECHNOLOGIES, S.L.U. have in the registry?
The registry currently lists 4 devices for LEASEIR TECHNOLOGIES, S.L.U.. Devices recorded under merged duplicate company entries are counted once.
Which registries list LEASEIR TECHNOLOGIES, S.L.U.'s devices?
Among its 4 most recently registered devices, LEASEIR TECHNOLOGIES, S.L.U. has devices listed in EUDAMED (2 devices), FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do LEASEIR TECHNOLOGIES, S.L.U.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for LEASEIR TECHNOLOGIES, S.L.U.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for LEASEIR TECHNOLOGIES, S.L.U.?
FDA recall records list 1 recall initiated by LEASEIR TECHNOLOGIES, S.L.U., the most recent initiated on 15 Dec 2025. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from LEASEIR TECHNOLOGIES, S.L.U. in the registry?
The most recently registered devices listed for LEASEIR TECHNOLOGIES, S.L.U. include Leaseir MHR Xcell, Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b) and Leaseir MHR Laser System.