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510(k) Data Aggregation

    K Number
    K181308
    Device Name
    SuperGrow 272, Ultimate 272
    Manufacturer
    Date Cleared
    2018-08-15

    (90 days)

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

    Super Grow Lasers

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SuperGrow 272 laser hat and the Ultimate 272 are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood – Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
    Device Description
    The SuperGrow 272 and the Ultimate 272 are non-invasive, low level laser therapy (LLLT) devices each containing 272 red, visible light, diode lasers. The devices are designed to deliver non-thermal energy to the hair follicles via photostimulation of the scalp. The SuperGrow 272 consists of 272 red, visible light, diode lasers operating at a 650 nanometer wavelength (maximum output power of each is 5 mW). The diodes are configured within a cap, enclosed between the outer shell and inner liner, both made of polyethylene terephthalate (PET). The Ultimate 272 is exactly the same as the SuperGrow 272 in every way except it is mounted on a stand. The same electrical design (power supply and the on/off switch) has been applied to the Ultimate 272.
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    K Number
    K172982
    Device Name
    SuperGrow 272, Ultimate 272
    Manufacturer
    Date Cleared
    2017-12-19

    (83 days)

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

    Super Grow Lasers

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SuperGrow 272 laser hat and the Ultimate 272 are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood – Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
    Device Description
    The SuperGrow 272 and the Ultimate 272 are non-invasive, low level laser therapy (LLLT) devices each containing 272 red, visible light, diode lasers. The devices are designed to deliver non-thermal energy to the hair follicles via photostimulation of the scalp. The SuperGrow 272 consists of 272 red, visible light, diode lasers operating at a 650 nanometer wavelength (maximum output power of each is 5 mW). The diodes are configured within a cap, enclosed between the outer shell and inner liner, both made of polyethylene terephthalate (PET). The Ultimate 272 is exactly the same as the SuperGrow 272 in every way except it is mounted on a stand. The same electrical design (power supply and the on/off switch) has been applied to the Ultimate 272. In the Ultimate 272, the SuperGrow 272, is inserted into a dome attached to a stand, and is intended for in-office use.
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