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510(k) Data Aggregation

    K Number
    K963947
    Device Name
    EPILASER NORMAL MODE RUBY LASER
    Manufacturer
    SPECTRUM MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1997-03-05

    (154 days)

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

    SPECTRUM MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epilaser" Normal Mode Ruby Laser is Intended Use: to hair removal intended effect of patients with skin types 1 - 4 through photothermolysis hair selective of in dermatology and plastic follicles surgery. This results in a prolonged growth delay.
    Device Description
    The Epilaser" Normal Mode Ruby Laser operates 694.3 at nanometers with pulse durations of 0.2 - 3.0 msec. uhe delivered energy 18 to the treatment site by an articulated arm. A water-cooled handpiece (7 mm or 10 mm) is firmly held against the skin for 2-3 seconds and the laser is then fired. The Bpilaser Normal Mode Ruby Laser is capable of producing energy fluences of 10-75 J/cm4.
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    K Number
    K955612
    Device Name
    RD-1200H NORMAL MODE RUBY LASER SYSTEM
    Manufacturer
    SPECTRUM MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1996-07-09

    (214 days)

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

    SPECTRUM MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spectrum Epilaser® has several indications for use based on the selective absorption of natural chromophores, particularly melanin and tattoos. The Ruby laser wavelength of 694.3 nanometers and the pulse duration of the normal mode system are well absorbed by these pigments. Indications for use include the treatment of benign epidermal pigmented lesions such as lentigines and café au lait and tattoos (blue and black).
    Device Description
    The Epilaser® is a normal mode ruby laser operating at 694.3 nanometers with fluence levels from 10-40 J/cm², a pulse duration from 200 usec to 3 msec and a spot size of 5-12 mm. The delivery system includes an articulating arm and cooled contact handpiece.
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