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510(k) Data Aggregation

    K Number
    K991993
    Device Name
    PHACOLASE ER: YAG LASER
    Manufacturer
    AESCULAP-MEDITEC GMBH
    Date Cleared
    1999-11-17

    (156 days)

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

    AESCULAP-MEDITEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap-Meditec Phacolase™ Er:YAG laser is intended for cutting, incision, excision, vaporization, and ablation of soft tissue in ophthalmology: Anterior capsulotomy Soft tissue surrounding the orbit of the eye
    Device Description
    The Aesculap-Meditec Phacolase™ Er: YAG laser emits a beam of coherent light at 2.94 microns.
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    K Number
    K983215
    Device Name
    MULTIPULSE CO2 LASER
    Manufacturer
    AESCULAP-MEDITEC GMBH
    Date Cleared
    1998-12-04

    (81 days)

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

    AESCULAP-MEDITEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap-Meditec CO2 Laser is intended for the ablation, vaporization, incision, excision, or cutting of soft tissue in oral surgery, E.N.T., gynecology, and dermatology.
    Device Description
    The Aesculap-Meditec MultiPulse-CO2 laser emits a beam of coherent light at 10.6 microns.
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    K Number
    K964128
    Device Name
    MCL 29 DERMABLATE ERBIUM LASER SYSTEM
    Manufacturer
    AESCULAP-MEDITEC GMBH
    Date Cleared
    1997-03-17

    (153 days)

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

    AESCULAP-MEDITEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).
    Device Description
    The MCL 29 Dermablate laser is an erbium: YAG of power at 2.94um.
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