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510(k) Data Aggregation

    K Number
    K211228
    Device Name
    Rosso
    Manufacturer
    Date Cleared
    2022-02-02

    (285 days)

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

    Rosso

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

    694 nm nanosecond (QS mode)
    Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink; Pigmented lesion removal (benign): - Cafe au lait spot - Ephalides, solar lentigo lentigines - Becker Nevus - Ota and Ito Nevus - Nevus spilus - Mongolian spot.
    694 nm picosecond (PS mode)
    Indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

    Device Description

    Not Found

    AI/ML Overview

    Based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or how ground truth was established for the Rosso device.

    The document is an FDA 510(k) clearance letter for the Rosso laser surgical instrument. It states that the device is substantially equivalent to legally marketed predicate devices and lists its "Indications for Use." This type of document confirms regulatory clearance but does not typically include the detailed technical study information that would be found in a clinical study report or a more comprehensive technical submission.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study, as this information is not present in the provided text.

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