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510(k) Data Aggregation

    K Number
    K183329
    Device Name
    Laser Hair Therapy
    Manufacturer
    OMM Imports, Inc. D/B/A Zero Gravity
    Date Cleared
    2019-01-16

    (47 days)

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

    OMM Imports, Inc. D/B/A Zero Gravity

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.
    Device Description
    The Laser Hair Therapy is a comb-shaped low level laser therapy (LLLT) device that emits laser light with the intention to promote hair growth. The device provides distributed laser to the scalp at 655+/-5nm while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The Laser Hair Therapy is designed as handheld product, and it consists of the power supply (adaptor and USB cable) and the control unit (RECREO device), as well as it is powered by the built-in rechargeable lithium battery. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 8 minutes treatment is completed.
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    K Number
    K172555
    Device Name
    SAPPHIRE, ELEVARE SAPPHIRE
    Manufacturer
    Omm Imports, Inc. d/b/a Zero Gravity
    Date Cleared
    2018-05-01

    (250 days)

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

    Omm Imports, Inc. d/b/a Zero Gravity

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAPPHIRE is an over -the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.
    Device Description
    The Sapphire device is an over-the-counter, battery powered, hand-held device that emits light energy in the blue spectrum for the treatment of mild to moderate inflammatory acne by emitting 50 mW/cm² of blue (415 nm +/- 5nm) light via an electric light emitting diode [LEDs] energy source. The Sapphire device operates by a cordless system drawing upon its rechargeable Li-Ion batteries to deliver the treatment. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. There are no user settings or adjustments required. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
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