LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K990902
    Device Name
    MODIFICATION OF MLT R694 RUBY LASER SYSTEM
    Manufacturer
    MEDICAL LASER TECHNOLOGIES LTD.
    Date Cleared
    1999-05-27

    (70 days)

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

    MEDICAL LASER TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MLT R694 Ruby Laser System (operating in the Q-Switched mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tatoo removal and treatment of benign pigmented lesions. The MLT R694 Ruby Laser System is restricted to sale to or use by licensed professionals in the United States
    Device Description
    The MLT R694 laser operates as a normal pulse or as a O-Switched rubv laser which emits a beam of coherent light at 694 nanometers. In the Q-Switched mode the beam has a much shorter pulse duration than in the normal or long pulse mode. The specifications for the normal or long pulse mode remain the same as described in K980187.
    Ask a Question
    K Number
    K982548
    Device Name
    MLT 30 LASER
    Manufacturer
    MEDICAL LASER TECHNOLOGIES LTD.
    Date Cleared
    1998-10-19

    (90 days)

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

    MEDICAL LASER TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The M.L.T. 30 CO2 laseris intended for the ablation, vaporization, incision, and or cutting of soft tissue in: Oral surgery, Dermatology, E.N.T., Gynaecology.
    Device Description
    The Medical Laser Technologies Ltd. MLT 30 CO2 Laser emits a beam of coherent light at 10.6 microns.
    Ask a Question
    K Number
    K980187
    Device Name
    MLT R694 RUBY LASER SYSTEM
    Manufacturer
    MEDICAL LASER TECHNOLOGIES LTD.
    Date Cleared
    1998-04-03

    (73 days)

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

    MEDICAL LASER TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MLT R694 Ruby Laser System is intended to remove unwanted body hair. Patient selection criteria include patients with skin types 1-4.
    Device Description
    The MLT R694 laser is a normal or long pulse ruby laser which emits a beam of coherent light at 694 nanometers.
    Ask a Question

    Page 1 of 1