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510(k) Data Aggregation

    K Number
    K132646
    Device Name
    SUNETICS CLINICAL BIO-STIMULATION LASER
    Manufacturer
    SUNETICS INTERNATIONAL MARKETING GROUP, LLC
    Date Cleared
    2013-12-20

    (116 days)

    Product Code
    OAP, NHN
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNETICS INTERNATIONAL MARKETING GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV. The Sunetics Clinical Laser is indicated to treat Androgenetic Alpopecia (Hair Loss) and to promote hair growth in Females who have Ludwig (Savin) 1-4, 11-1, 11-2, or frontal patterns of hair loss and Fitzpatrick Skin Types I to IV.
    Device Description
    The Sunetics Clinical Laser (model "G" & model "W2326") is a stationary, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in both Males and Females. The Sunetics Clinical Laser device provides distributed red laser light dispersing from an "Open Panel" Hood utilizing laser modules with a 650 nm wavelength, <5 mW output power, producing a continuous wave "CW" output beam. The "Open Panel" Hood is designed to maximize the delivery of the coherent laser light to effectively cover the entire scalp of the user during treatment.
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    K Number
    K121920
    Device Name
    LASERBRUSH
    Manufacturer
    SUNETICS INTERNATIONAL MARKETING GROUP, LLC
    Date Cleared
    2013-06-27

    (360 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNETICS INTERNATIONAL MARKETING GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sunetics LaserBrush is indicated to treat Androgenetic Alopecia, promote hair growth and prevent further hair loss in males who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV & also in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss & Fitzpatrick Skin Types I to IV.
    Device Description
    The Sunetics LaserBrush consists of a handheld low-level laser device intended to promote hair growth. Depending upon the Sunetics LaserBrush model, the device provides distributed laser light using seven (7), nine (9), or twelve (12), collimated, 650 nm, <5 mW laser modules, while brush bristles simultaneously part the user's hair to ensure that the laser light reaches the user's scalp.
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