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510(k) Data Aggregation

    K Number
    K152889
    Device Name
    SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
    Manufacturer
    BIORENEW LABS, LLC
    Date Cleared
    2015-12-30

    (91 days)

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

    BIORENEW LABS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonilase Blue is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean is a hand held OTC device intended to emit energy in the light spectrum for use in the treatment of mild to moderate acne vulgaris. The Sonilase Blue-UV Clean Plus is a hand held OTC device intended to emit energy in the blue region of the light spectrum for use in the treatment of mild to moderate acne vulgaris.
    Device Description
    The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus are modular system devices that offer blue light therapy for the treatment of mild to moderate acne vulgaris. The Sonilase Blue device components include the handheld unit containing the LED module with 3 (415nm) LEDs . attachable clear plastic lens cover. an adjunct attachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles. The Sonilase Blue-Clean device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) attachable opaque lens cover, an adjunct attachable cleansing brush head. recharging stand. 7.4 v LI-ION BATTERY. 9V UL approved power supply and goggles. The Sonilase Blue-UV Clean Plus device components include the handheld unit containing the LED module with 3 blue LEDs (415nm) and 3 UV sanitizing LEDs , attachable opaque lens cover, a detachable cleansing brush head, recharging stand, 7.4 v LI-ION BATTERY, 9V UL approved power supply and goggles. The Sonilase Blue, Sonilase Blue-UV Clean, and Sonilase Blue-UV Clean Plus devices operate by a cordless system drawing upon their 7.4V rechargeable LI-ION battery to deliver the treatment. The Sonilase Blue. Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus utilize blue light at 415 nm +/- 5nm. The Sonilase Blue is applied directly to the skin to ensure consistent administration of light during each treatment. The Sonilase Blue-Clean and Sonilase Blue-UV Clean Plus are applied to the skin with the cleansing brush still attached, but the amount of treatment energy (Dose) delivered to the skin is the same. The Sonilase Blue, Sonilase Blue-Clean, and Sonilase Blue-UV Clean Plus have a skin sensor that will not allow the device to illuminate unless it is in contact with the skin as a safety feature. The Sonilase Blue, Sonilase Blue- Clean, and Sonilase Blue-UV Clean Plus devices do not contain any user serviceable components. The devices are sold as Over the Counter (OTC).
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    K Number
    K132613
    Device Name
    SONILASE LIGHT THERAPY DEVICE
    Manufacturer
    BIORENEW LABS, LLC
    Date Cleared
    2014-02-05

    (168 days)

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

    BIORENEW LABS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonilase™ Light Device Red is used to treat periorbital wrinkles and fine lines around the eyes (i.e., crow's feet).
    Device Description
    The Sonilase Light Deviceis a modular system that offers red light therapy for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The Sonilase system components include the handheld unit containing the LED module , attachable clear plastic lens cover, an adjunct attachable cleansing brush head, recharging stand, 7.4V LI-ION BATTERY, 9V UL approved power supply , UV Sanitizing cradle and goggles. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
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