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510(k) Data Aggregation

    K Number
    K061850
    Device Name
    MINI-YAG LASER
    Manufacturer
    AMERICAN LASERS, INC.
    Date Cleared
    2006-09-29

    (91 days)

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

    AMERICAN LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - FOR INCISION, EXCISION, ABLATION, AND VAPORIZATION OF SOFT TISSUE FOR 1. GENERAL DERMATOLOGY. - THE 1064 NM WAVELENGTH IS INDICATED FOR: 2. DARK INK TATTOO REMOVAL TREATMENT OF PIGMENTED LESIONS SUCH AS NEVUS OF OTA. REMOVAL OR LIGHTENING OF HAIR. TREATMENT OF COMMON NEVL - THE 532 NM WAVELENGTH IS INDICATED FOR: 3. REMOVAL OF LIGHT INK (RED, TAN, PURPLE, AND ORANGE) TATTOOS TREATMENT OF COMMON NEVI TREATMENT OF CAFÉ AU-LAIT SPOTS. TREATMENT OF SEBORRHEIC KERATOSES TREATMENT OF VASCULAR LESIONS, INCLUDING FACIAL AND LEG VEINS, TELENGIECTASIAS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST PICMENTED LESINS SUCH AS LENTIGINES, AND EPHELIDES. - HERMINGLASER SYSTEM FROMAAMERICAN LASERS, INC. IS A SQLD STATE . Nd YAG LASER SYSTEM THAT PROVIDES TWO WAVELENGTHS, 1064nm AND 532nm FOR THE REMOVAL OF BLACK AND BLUE TATTOOS AS WELL AS SUPERFICIAL EPIDERMAL PIGMENTED LESIONS AND SMALL VASCULAR LESIONS. - TATTOOS REMOVAL: THE 532nm WAVELENGTH CAN BE USED TO REMOVE RED, TAN, PURPLE, AND ORANGE TATTOO INKS. THE 1064mm WAVELENGTH CAN BE USED TO REMOVE DARK (BLACK) AND BLUE COLOR INKS. - THE 532um WAVELENCIA CAN ALSO BLE USED POR REMOVAL OF SUPERIACAL BENIGN, PIGMENTED SKIN LESIONS SUCH AS LENTIGINES AND CAFE-AU-LAIT, TREATMENT OF COMMON NEVI, AND SEBORRHEIC KERATOSES. ALSO THE 532am WAVELENGTH CAN BE USED TO REMOVE SMALL VASCULAR LESIONS SUCH AS TELAGIECTASIAS, SMALL FACIAL AND LEG VEINS, ANGIOMAS, HEMANGIOMAS, PORT-WINE STAINS, AND MOST OTHER BENIGN PIGMENTED LESIONS SUCH AS LENTIGINES AND EPHELIDES. THE 1064mm WAVFI.ENGTH CAN ALSO RE USED TO TREAT PIGMENTED LESIONS SUCH AS THE NEVUS OF OTA, REMOVAL OR LIGHTENING OF HAIR, TREATMENT OF COMMON NEVI.
    Device Description
    THE MINI_YAG LASER IS A Nd: YAG LASER WITH EMITTED WAVELENGTH AT 1064 NANOMETERS. WITH THE FREQUENCY DOUBLER INSTALLED, A 532 NANOMETER WAVELENGTH IS EMITTED. THE 1064 NM IS IN THE NEAR-INFRARED PORTION OF THE SPECTRUM, WHILE THE 532 NM IS VISIBLE AS A GREEN LIGHT, LASER ENERGY IS DELIVERED DIRECTLY TO THE SKIN LESION VIA THE HANDPIECE, WHICH PRODUCES A CIRCULAR BEAM ON THE SKIN. THE MINI-YAG LASER IS EQUIPPED WITH SAFETY FEATURES IN CONFORMANCE WITH 21CFR PART 1040.
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    K Number
    K974142
    Device Name
    HM-RUBY
    Manufacturer
    AMERICAN LASERS, INC.
    Date Cleared
    1998-01-28

    (86 days)

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

    AMERICAN LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALL 7A7700 FOR 02 (D) LIGHTENING RED I-xcEPT R TONIC 7-0 R JRZATMENT 1 151 FRIDERMAL PIGATENTED 0 L o 7 A NEVUS of FOR RZATMITENT (
    Device Description
    Not Found
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    K Number
    K970475
    Device Name
    MM-RUBY
    Manufacturer
    AMERICAN LASERS, INC.
    Date Cleared
    1997-09-29

    (234 days)

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

    AMERICAN LASERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Q-SWITCHED MODE: FOR LIGHTENING OF TATTOOS (BLACK, YELLOW, AND BLUE INKS). LONG-PULSE MODE: FOR TREATMENT OF BENIGN SUPERFICIAL PIGMENTED SKIN LESIONS --LENTIGINES -- CAFE-AU-LAIT -- - - - - - --- EPHELDES never of OR -
    Device Description
    Not Found
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