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510(k) Data Aggregation

    K Number
    K113868
    Device Name
    EPLUS SKIN TREATMENT SYSTEM
    Manufacturer
    SYNERON, LTD.
    Date Cleared
    2012-06-11

    (164 days)

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

    SYNERON, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ePlus Skin Treatment system is intended for dermatological procedures. The DS applicator is indicated for the removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction*. The DSL applicator is indicated for hair removal, permanent hair reduction*. The applicator is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The LV applicator is indicated for treatment of vascular lesions. The LVA applicator is indicated for treatment of vascular lesions. The WRA applicator is indicated for non invasive wrinkles treatment. The SR applicator is intended for superficial benign vascular and pigmented lesion treatment such as: lentigines, freckles, telangiectasia, rosacea, poikiloderma, angioma, sun spots and age spots. The SR treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body. The SRA applicator is intended for superficial benign vascular and pigmented lesion treatment such as: lentigines. freckles, telangiectasia, rosacea, poikiloderma. angioma, sun spots and age spots. The SRA treatment may be performed on body areas such as the face, chest, hands and arms. It can be also performed on sporadic lesions anywhere on the body. The AC applicator is indicated for the treatment of moderate inflammatory acne vulgaries. The Sublative RF applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. The Sublime applicator is indicated for non invasive wrinkles treatment. * 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 regimen
    Device Description
    The ePlus skin treatment system is a multi-application system that provides a variety of skin treatments. The system combines Syneron's previously cleared Polaris, Aurora and eTwo treatment Systems and their applicators. The ePlus skin treatment system delivers two ranges of electromagnetic energy to the skin tissue through the system applicators: - Optical radiation through Laser or IPL (Intense Pulse Light) in the visible & near-IR range. 2. RF current conducted through the tissue at 1MHz
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    K Number
    K110672
    Device Name
    ETWO SKIN TREATMENT SYSTEM
    Manufacturer
    SYNERON, LTD.
    Date Cleared
    2011-10-03

    (208 days)

    Product Code
    GEI, OUH
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERON, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The eTwo Skin Treatment system is intended for dermatological procedures. The Sublative RF applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. The Sublime applicator is indicated for non invasive wrinkles treatment.
    Device Description
    The eTwo skin treatment system is a mobile operating system combining two treatment applicators: - . Sublative RF applicator, which is intended for dermatological procedures requiring ablation and resurfacing of the skin and for ablation and resurfacing of the skin for wrinkle treatment. Sublative RF's technology enables skin remodeling with minimal downtime. In fractional treatment, small damaged areas are created in the skin, accelerating tissue healing process after treatment. - Sublime applicator, which is intended for non invasive wrinkles treatment. The applicator uses pulsed infrared light combined with RF energy for Deep Tissue Stimulation leading to skin tightening. Thermal stimulation of the deep dermis contributes to collagen enrichment and tissue remodeling.
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