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510(k) Data Aggregation

    K Number
    K091420
    Date Cleared
    2009-10-14

    (154 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    1550 nm. The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

    1925 nm: The Fraxel re:store 1925 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

    Device Description

    Fraxel re:store (SR 1500) Laser System and Accessories

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "Fraxel re:store (SR 1500) Laser System and Accessories." This document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria.

    FDA 510(k) clearances are based on demonstrating "substantial equivalence" of a new device to a legally marketed predicate device, not necessarily on specific performance metrics or detailed clinical studies with acceptance criteria in the way a PMA approval might be. The letter confirms the device is cleared for marketing based on equivalence to existing devices for the stated indications for use (dermatological procedures coagulation of soft tissue, skin resurfacing, treatment of dyschromia, cutaneous lesions, periorbital wrinkles, acne scars, and surgical scars).

    Therefore, I cannot provide the requested information based on the text provided.

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