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510(k) Data Aggregation

    K Number
    K974380
    Device Name
    REJUVENESS
    Manufacturer
    REJUVENESS PHARAMCEUTICALS, INC.
    Date Cleared
    1998-04-03

    (164 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    REJUVENESS PHARAMCEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS - ReJuveness™ is effective in the management of hypertrophic and keloid scars. . - Consistent use of ReJuveness ™ can reduce hypertrophic and keloid scarring. . PREVENTION OF HYPERTROPHIC AND KELOID SCARS - ReJuveness may be useful as a prophylaxis on closed scars to aid in the prevention of . hypertrophic and keloid scarring. - If used following surgical procedures, ReJuveness™ may prevent hypertrophic and . keloid scarring. - ReJuveness™ can be used as soon as the wound is closed, dry and the sutures have . been removed. - ReJuveness™ may prevent scarring disorders. .
    Device Description
    REJUVENESS IS A SOFT, DURABLE REUSABLE SILICONE OCCLUSIVE SHEETING. IT IS A MEDICAL-GRADE, PURE SILICONE SHEETING THAT IS MANUFACTURED IN THE USA. REJUVENESS IS A NON-INVASIVE MEDICAL DEVICE THAT REDUCES HYPERTROPHIC AND KELOID SCARS RESULTING FROM BURNS, SURGICAL PROCEDURES AND TRAUMATIC EVENTS. IT SOFTENS, SMOOTHES AND FLATTENS SCARS AND RESTORES THEM TO A MORE NORMAL TEXTURE AND COLOR. WHEN USED DAILY AS DIRECTED, REJUVENESS HAS THE POTENTIAL TO DRAMATICALLY IMPROVE THE APPEARANCE OF BOTH OLD AND REJUVENESS HAS BEEN CIJNICALLY PROVEN EFFECTIVE IN THE NEW SCARS. MANAGEMENT OF HYPERTROPHIC AND KELOID SCARS AND MAY RELIEVE THE BURNING AND ITCHING THAT IS CHARACTERISTIC OF SCARRING DISORDERS. REJUVENESS HAS ALSO SHOWN SUCCESS IN THE PREVENTION OF HYPERTROPHIC AND KELOID SCARS WHEN APPLIED FOLLOWING SURGICAL PROCEDURES.
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