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510(k) Data Aggregation

    K Number
    K051268
    Device Name
    RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
    Manufacturer
    RADIANCY, LTD.
    Date Cleared
    2005-07-06

    (51 days)

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

    RADIANCY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiancy Acne System with ClearTouch Light Unit Assembly ("Radiancy Acne System") is intended to provide phototherapeutic light to the body. The Radiancy Acne System is generally indicated to treat dermatological conditions. The Radiancy Acne System is specifically indicated to treat mild to moderate inflammatory acne vulgaris which includes pustular inflammatory acne, in patients with Fitzpatrick skin types I-VI.
    Device Description
    The ClearTouch LUA is mounted on the hand piece of Radiancy's SpaTouch Photoepilation System (the "SpaTouch"), or on the hair removal / acne hand piece of Radiancy's SkinStation (the "SkinStation"), in order to treat acne vulgaris (the "Radiancy Acne System"). The Radiancy Acne System consists of two green-coated flash lamps. The Radiancy Acne System produces a wavelength spectrum of 430 – 1100 nm with a pulse duration of 35 msec and has a spot size of 22 x 55 mm.
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    K Number
    K992482
    Device Name
    DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)
    Manufacturer
    RADIANCY, LTD.
    Date Cleared
    1999-12-27

    (154 days)

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

    RADIANCY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeLight™ II HR System is intended for removal of unwanted body and/or facial hair in adults. The System is specifically indicated for dermatological use by physicians and healthcare professionals.
    Device Description
    The DeLight™ II HR System is a light-based medical device intended for removal of unwanted hair by using a selective photothermal treatment.
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