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    Leaseir MHR Xcell

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Leaseir MHR Xcell

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·LEASEIR TECHNOLOGIES, S.L.U.·1 device

    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 surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO

    FDA Enforcement
    Class II ·Completed·LEASEIR TECHNOLOGIES SLU·January 28, 2026

    Leaseir MHR Laser System

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·LEASEIR TECHNOLOGIES, S.L.U.·1 device

    Tasectan 20 sachets

    Device
    EU MDR · Eu Md Class 3 ·Noventure SL·On the market·1 country

    Tasectan 15 capsules

    Device
    EU MDR · Eu Md Class 3 ·Noventure SL·On the market·1 country

    Tasectan sachets

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Noventure SL·1 device

    Tasectan capsules

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Noventure SL·1 device

    Noventure SL

    Manufacturer
    🇪🇸 Spain·ISTITUTO SUPERIORE DI SANITA' and ISTITUTO SUPERIORE DI SANITA'

    RADIOLOGÍA, S.A.

    Manufacturer
    🇪🇸 Spain·SGS Belgium NV

    Sycai Technologies S.L.

    Manufacturer
    🇪🇸 Spain·Kiwa Dare B.V.

    CARDIVAIS S.A.

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·28 Devices·SGS Belgium NV

    IONCLINICS & DEIONIC, S.L.

    Manufacturer
    🇪🇸 Spain·2 Basic UDI-DIs·4 Devices·TUV Rheinland Italia SRL

    Tecnoclínic SA

    Manufacturer
    🇪🇸 Spain·25 Basic UDI-DIs·83 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

    Noventure SL

    Manufacturer
    🇪🇸 Spain·3 Basic UDI-DIs·3 Devices·KIWA CERMET ITALIA S.P.A. and ISTITUTO SUPERIORE DI SANITA'

    S.E. Carburos Metálicos, S.A.

    Manufacturer
    🇪🇸 Spain·257 Basic UDI-DIs·257 Devices·SGS Belgium NV, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS, DNV Product Assurance AS, and DNV Product Assurance AS

    ITH 1343070 1

    Certificate
    MDR QMS·IONCLINICS & DEIONIC, S.L.·TUV Rheinland Italia SRL

    CGP000124

    Certificate
    MDR QA·Tecnoclínic SA·ISTITUTO SUPERIORE DI SANITA'

    22M00045CRT01

    Certificate
    MDR QMS·Sycai Technologies S.L.·Kiwa Dare B.V.