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510(k) Data Aggregation

    K Number
    K092734
    Device Name
    E-LIGHT LINE
    Manufacturer
    ESPANSIONE MARKETING S.P.A
    Date Cleared
    2010-09-20

    (381 days)

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

    ESPANSIONE MARKETING S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-Light Line devices are intended for dermatological use by physicians and healthcare professionals as the following: IPL Technology is intended for: - Treatment of Acne (from 390 to 1200nm filter) - Treatment of vascular and benign pigmented lesions, cutaneous lesions including warts, scars, striae , and facial and leg veins (from 550 to 1200nm filter). - Removal of unwanted hair in all skin types (from 570- to 1200nm filter) LED Technology is intended: - Yellow LED 594 nm for treatment of periorbital wrinkles and rhytides - Blue LED 428nm to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris - Red LED 632nm for treatment of superficial, benign vascular and pigmented lesions VACUUM Technology is intended to: - Improve Lymphatic circulation in the treated area
    Device Description
    The E-light Line is a family of devices with three types of output emitted from different handpieces. The outputs of the E-light Line are Intense Pulsed Light (IPL), LED and Vacuum. These outputs may be issued from different handpieces. The output handpieces are: - IPL handpiece - Led handpiece - Led Body Band - Led Masks - Vacuum handpiece Only one output source works at a time. All the E-Light line devices include a Main Unit that controls and manages the IPL, LED or Vacuum handpiece. The Main Unit contains all circuitry to control the device as the capacitor charge system, the microcontroller and all the electronic parts. The E-light line devices are: - Trinity Plus - Evoluzione Plus - EPI-C Plus The E-Light Trinity Plus supports all the technologies (IPL, LED and Vacuum) and therefore all the handpieces. The E-Light Evoluzione Plus and EPI-C plus support the IPL and LED Technologies and therefore all the handpiece with the exception of the Vacuum handpieces.
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