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510(k) Data Aggregation

    K Number
    K130225
    Device Name
    QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE
    Manufacturer
    SILVERBAY LLC, D/B/A QUASAR BIO-TECH
    Date Cleared
    2013-07-11

    (163 days)

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

    SILVERBAY LLC, D/B/A QUASAR BIO-TECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quasar C100 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of full-face wrinkles. The Baby Quasar Plus Wrinkle Reduction Device is intended to emit energy in the red and iR region of the spectrum, specifically indicated for the treatment of fullface wrinkles. The Quasar MD Plus Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of fullface wrinkles.
    Device Description
    The Silver Bay, Quasar C100. Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 20 cm² containing the LED array and an on/off switch. The device is made of ABS plastic with clear polycarbonate lenses covering the LED light source. The Quasar C100 uses a 12 volt wall mount power supply. The C100 light delivery system used for applying therapy for the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 20 red LEDs and 20 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure. The Silver Bay, Baby Quasar Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 8.7 cm 2 containing the LED array and an on/off switch. The device is made of anodized aluminum. The Baby Quasar Plus uses a 12 volt wall mount power supply. The Baby Quasar Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850nm) light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure. The Silver Bay, Quasar MD Plus Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head size of 15.2 cm 2 containing the LED array and an on/off switch. The device is made of anodized aluminum. The Baby Quasar Plus uses a 12 volt wall mount power supply. The Quasar MD Plus light delivery system used for applying therapy for the use in the treatment of full-face wrinkles, by emitting at least 65 mWcm² of red and near infrared (610nm to 850m), light via an electric light emitting diodes [LEDs] energy source. There are 12 red LEDs and 12 infrared LEDs in the head. The device is not intended for ocular applications or direct eve exposure.
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