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510(k) Data Aggregation

    K Number
    K081541
    Date Cleared
    2009-02-23

    (266 days)

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

    DERMABLATE EFFECT

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

    The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes).

    The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures.

    The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW).

    The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne.

    The Acoustic Wave is intended for the activation of connective tissue.

    Device Description

    The Dermablate Effect is a pulsed Er:YAG laser emitting a wavelength of 2940 nm, that can optionally be equipped with a pulsed light module (APL) and an acoustic wave module (AW).

    AI/ML Overview

    Unfortunately, I cannot directly help you with your request. The provided text is a 510(k) summary for a medical device (Dermablate Effect). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

    Key issues preventing me from fulfilling your request are:

    • Absence of Acceptance Criteria and Performance Data: The 510(k) summary explicitly states "Nonclinical Performance Data: None" and for "Clinical Performance Data," it only mentions a "Fractional Er:YAG histological report of Prof. D. Cassuto" without providing any specific criteria, metrics, or measured performance values. This means there's no information about acceptance criteria or how the device's performance was quantitatively evaluated against them.
    • Lack of Detailed Study Information: The brief mention of a "histological report" is not a detailed study description. It doesn't contain the essential information you're asking for, such as sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics.
    • Focus on Substantial Equivalence, Not De Novo Performance: The 510(k) process is about demonstrating substantial equivalence to pre-existing devices, not necessarily proving novel performance against a predefined set of acceptance criteria in a detailed clinical trial like a PMA (Pre-Market Approval) submission might require.

    To get the information you are looking for regarding acceptance criteria and detailed study data, you would typically need to consult a more comprehensive clinical trial report or a PMA submission for a novel device, rather than a 510(k) summary.

    Therefore, I cannot generate the table or answer the specific questions because the necessary data is not present in the provided text.

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