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510(k) Data Aggregation

    K Number
    K964520
    Device Name
    PARASCAN SCANNING DEVICE
    Manufacturer
    LASERSCOPE
    Date Cleared
    1997-02-10

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K974633
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO, soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.

    Device Description
    • ParaScan™ Scanning Device A.
    • CBH-1 Collimated Beam Handpiece B.
    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving a device meets them. The provided text is a summary of safety and effectiveness for a medical device called ParaScan Scanning Device or CBH-1 Collimated Beam Handpiece, focusing on its regulatory classification, indications for use, and comparison with a predicate device. It does not include details about device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

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