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510(k) Data Aggregation

    K Number
    K192539
    Device Name
    Deka Luxea
    Manufacturer
    El..EN. Electronic Engineering SPA
    Date Cleared
    2019-12-16

    (91 days)

    Product Code
    GEX, ONF
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    El..EN. Electronic Engineering SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lessions, hair removal and permanent harr reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. RUBER, LILAC Pulsed Light handpieces: Permanent hair reduction, photocoagulation of benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types. as indicated in the following table: 500-1200nm: Benign Vascular lesions Skin Types I, II; Blood vessels Skin Types I, II. 520-1200nm: Benign Vascular lesions SkinType III; Blood Type III; Benign Pigmented lesions Skin Types I, II. 550-1200nm: Hair reduction Skin Types I, II; Benign Pigmented lesions Skin Type Ill. 600-1200nm: Hair reduction Skin Type Ill. 650-1200nm: Hair reduction Skin Type IV; Benign Pigmented lesions Skin Type IV. LAZUR Pulsed Light handpiece: The handpiece (with and without contact-cooling) is indicated for: -The treatment of moderate inflammatory acne vulgaris. -The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). -The treatment of benign cutaneous lesions including warts, scars and striae. -The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. - Use on all skin types (Fitzpatrick I-VI). VIRIDIS Pulsed Light handpiece: Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial andleg veins), and the treatment of benign pigmented lesions.
    Device Description
    The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser - PRISMA: 1064nm O-Switched laser - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550mm filter - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.
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