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510(k) Data Aggregation

    K Number
    K021975
    Device Name
    LASERSYSTEM BEAUTYSTAR 532
    Manufacturer
    ASCLEPION-MEDITEC AG
    Date Cleared
    2002-09-13

    (88 days)

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

    ASCLEPION-MEDITEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BeautyStar 532 is intended for Vaporization and Photocoagulation of vascular and pigmented lesions in soft tissue.
    Device Description
    The Laser System BeautyStar 532 consists of a laser enclosure. fiber optic delivery system and an computer controlled treatment parameter interface.
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    K Number
    K014057
    Device Name
    DERMASTAR ER:YAG LASER SYSTEM
    Manufacturer
    ASCLEPION-MEDITEC AG
    Date Cleared
    2002-03-08

    (88 days)

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

    ASCLEPION-MEDITEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DermaStar Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
    Device Description
    The DermaStar Er: YAG Laser System is an Erbium:YAG laser with a wavelength of 2.94um. It consists a laser enclosure and fiber optic delivery system (including hand piece).
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    K Number
    K013940
    Device Name
    LASER SYSTEM YELLOWSTAR
    Manufacturer
    ASCLEPION-MEDITEC AG
    Date Cleared
    2002-02-26

    (89 days)

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

    ASCLEPION-MEDITEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The YellowStar is intended for treatment of vascular and pigmented lesions.
    Device Description
    The Laser System YellowStar consists of a laser enclosure, fiber optic delivery system and an computer controlled treatment parameter interface.
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    K Number
    K002031
    Device Name
    PHACOFRAGMENTATION SYSTEM MEGATRON
    Manufacturer
    ASCLEPION-MEDITEC AG
    Date Cleared
    2000-12-27

    (177 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASCLEPION-MEDITEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002032
    Device Name
    C02 LASER MULTIPULSE
    Manufacturer
    ASCLEPION-MEDITEC AG
    Date Cleared
    2000-09-11

    (70 days)

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

    ASCLEPION-MEDITEC AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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