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510(k) Data Aggregation

    K Number
    K112141
    Device Name
    SMARTEPIL,DEPILASE YAG LASE PLUS
    Date Cleared
    2012-04-13

    (262 days)

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

    CASTLE LASER SYSTEMS, LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CLS001 Laser System is intended to effect stable, long-term or permanent hair reduction, in Fitzpatrick skin types I-VI, including sun tanned skin types. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing after a treatment regime The CLS001 Laser System is intended to effect coagulation and haemostatis of vascular lesions in Fitzpatrick skin types I-VI, including suntanned skin types.
    Device Description
    The CLS001 Laser System is an analog, pulsed Nd: YAG laser utilizing the Nd: YAG crystal as the lasing medium. It operates at the wavelength of 1064 nanometers. Laser activation is controlled by a footswitch mechanism. Physically, the system weighs 66 pounds, is 13.8 inches high, 23.6 inches wide and 17.3 inches deep. The electrical requirements are 220/240 VAC single phase, 50/60 Hz and 8 amps.
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