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510(k) Data Aggregation

    K Number
    K160821
    Device Name
    Tria Sapphire
    Manufacturer
    TRIA BEAUTY, INC.
    Date Cleared
    2016-06-15

    (83 days)

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

    TRIA BEAUTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tria Sapphire is indicated for the treatment of mild to moderate inflammatory acne. It is intended for over-the-counter use.
    Device Description
    The Tria Sapphire is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
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    K Number
    K141868
    Device Name
    TRIA FANP
    Manufacturer
    TRIA BEAUTY, INC.
    Date Cleared
    2014-12-30

    (173 days)

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

    TRIA BEAUTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tria FANp is an over-the-counter device indicated for the treatment of periorbital wrinkles (crow's feet).
    Device Description
    The Tria FANp is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
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    K Number
    K130459
    Device Name
    TRIA FAN SYSTEM
    Manufacturer
    TRIA BEAUTY, INC.
    Date Cleared
    2013-10-25

    (245 days)

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

    TRIA BEAUTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tria FAN is indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area.
    Device Description
    The Tria FAN System is a semiconductor diode laser system that delivers infrared light at a wavelength of 1450 nm ± 50 nm.
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    K Number
    K120737
    Device Name
    TRIA LASER HAIR REMOVAL SYSTEM
    Manufacturer
    TRIA BEAUTY, INC.
    Date Cleared
    2012-09-13

    (188 days)

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

    TRIA BEAUTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TRIA is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. TRIA is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. Permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
    Device Description
    TRIA is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm +/- 20%.
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    K Number
    K090312
    Device Name
    TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
    Manufacturer
    TRIA BEAUTY, INC.
    Date Cleared
    2010-01-05

    (333 days)

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

    TRIA BEAUTY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATS-1 OTC is generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris. It is intended for over-the-counter use.
    Device Description
    The ATS-1 OTC is a handheld, electrically powered device that uses LEDs (light emitting diodes) to produce therapeutic blue light.
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