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510(k) Data Aggregation

    K Number
    K964031
    Device Name
    DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
    Manufacturer
    Date Cleared
    1996-12-23

    (76 days)

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

    SLT-J LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    substantially equivalent to other pulsed Nd: Y AG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and microscopic procedures.
    Device Description
    The DCL8 Enhanced Pulsed Nd:YAG laser system has the same operating characteristics as the pulsed Nd: Y AG laser systems offered by Sunrise Technologies and American Dental Technologies with respect to average power to tissue, pulse rates, operating controls and indicators. The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd: YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems.
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    K Number
    K960086
    Device Name
    DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM
    Manufacturer
    Date Cleared
    1996-06-03

    (144 days)

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

    SLT-J LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    substantially equivalent to other pulsed Nd: YAG laser systems currently in interstate commerce for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures.
    Device Description
    The DCL8 Enhanced Pulsed Nd: YAG laser system incorporates a red diode aiming beam, touch pad controls for setting of operating parameters, and uses the same input power (110 VAC) as the pulsed Nd: YAG laser systems offered by Sunrise Technologies and American Dental Technologies. The DCL8 Enhanced Pulsed Nd:YAG laser system uses the industry standard SMA 905 fiberoptic connector system for its fiberoptic delivery systems. The DCL8 Enhanced Pulsed Nd: YAG laser system can be operated by either a footswitch or a fingerswitch.
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    K Number
    K960905
    Device Name
    SDL DIODE LASER SYSTEM
    Manufacturer
    Date Cleared
    1996-06-03

    (90 days)

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

    SLT-J LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Not Found
    Device Description
    Near-infrared Diode Laser System
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