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510(k) Data Aggregation

    K Number
    K091568
    Device Name
    LH-75 PHOTOTHERAPY SYSTEM
    Manufacturer
    LERNER MEDICAL DEVICES, INC.
    Date Cleared
    2009-11-05

    (156 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    LERNER MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The LH-75 Phototherapy System is intended for use on all skin types (I -VI).
    Device Description
    Not Found
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    K Number
    K090097
    Device Name
    LH-75T PHOTOTHERAPY SYSTEM
    Manufacturer
    LERNER MEDICAL DEVICES, INC.
    Date Cleared
    2009-02-26

    (42 days)

    Product Code
    FTC, CLA
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    LERNER MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LH-75T Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The LH-75T Phototherapy System is intended for use on all skin types (I -VI).
    Device Description
    The LH-75T Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 mm) light for use in phototherapy and allows delivery of controlled doses! The LH-75T consists of a Console that contains the electronics and a Handpiece that contains the lamp and the ballast. The console and handpiece are connected with an electrical cable. A Spot Treatment Attachment (LP-3) jand a Fiber-optic Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Attachment (LB-10) are connected to the handpiece for selective treatment of skin lesions without exposure of adjacent, healthy tissues. The desired dose is selected using controls on the panel of the console and activated with either a switch on the panel or foot-switch. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
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    K Number
    K040062
    Device Name
    LEVIA PHOTOTHERAPY SYSTEM
    Manufacturer
    LERNER MEDICAL DEVICES, INC.
    Date Cleared
    2004-02-13

    (31 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    LERNER MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The Levia Phototherapy System is intended for use on all skin types (I -VI).
    Device Description
    The Levia Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 nm) light for use in phototherapy and allows delivery of controlled doses. The desired dose is selected using controls on the panel of the Light Source and activated with a switch on the panel or remotely by a foot switch. A Spot Handpiece and a Fiber-optic Brush allow for selective treatment of skin lesions without exposure to neighboring, healthy tissues. The Spot Handpiece and Fiber-optic Brush connect to Light Source with a flexible Light Guide. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
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