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510(k) Data Aggregation

    K Number
    K130793
    Device Name
    NEWA SKIN THERAPY SYSTEM
    Manufacturer
    ENDYMION MEDICAL LTD
    Date Cleared
    2013-08-16

    (147 days)

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

    ENDYMION MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndyMed Newa is a prescription home use device intended for non-invasive treatment of mild to moderate facial wrinkles and rhytides
    Device Description
    The Newa™ is a noninvasive, non-ablative, prescription home use hand held device consisting of: - User interface . - Programmable Logic controller (PLC) ● - RF power module ● - Power Supply . - RF Electrodes ● The interface allows the selection of heating level by using the Power Level Switch as follows: - "0" mode = the device is "OFF". . - . "1" mode = low heating level. - . "2" mode = high heating level. The PLC is a specially configured computer that provides the operational and safety function of the system. The RF power module provides RF energy to the active tip, producing a sinusoidal signal at a 1MHz frequency. Based on 3DEEP® technology, the Newa™ is comprised of 3 pairs of bipolar RF electrodes. The RF is emitted into the skin creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis, dermis or hypodermis.
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    K Number
    K083461
    Device Name
    IMAGINE TC SKIN THERAPY SYSTEM
    Manufacturer
    ENDYMION MEDICAL LTD
    Date Cleared
    2009-07-24

    (245 days)

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

    ENDYMION MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imagine TC Skin Treatment System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides
    Device Description
    The Imagine Skin Treatment System is a noninvasive, non-ablative device consisting of: User interface Programmable Logic controller (PLC) RF power module Thermoelectric cooling (TEC) module Two treatment handpieces (small and large) The interface allows the selection of treatment parameters by pressing on the treatment buttons; LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. Handpieces incorporating: Treatment handpieces with thermoelectric cooling (TEC) that maintains electrodes at ambient temperature. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 1000 kHz frequency
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