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510(k) Data Aggregation

    K Number
    K050218
    Device Name
    WAVELIGHT SINON
    Manufacturer
    WAVELIGHT LASER TECHNOLOGIE AG
    Date Cleared
    2005-02-15

    (15 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K040433,K991285,K910422,K971814,K040384
    Why did this record match?
    Device Name :

    WAVELIGHT SINON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. In the Q-Switch Mode, for the cutting, vaporization, or ablation of soft tissue. This includes the removal of tattoos and treatment of benign pigmented lesions.
    2. In the Free-Running Mode, for the removal of unwanted hair in patients with Fitzpatrick skin types of I and II.
    Device Description

    The SINON is a 694 nm Ruby laser system which can be operated in two different modes. The quality-switch or Q-switch or QS Operating Mode is characterized by extremely short pulse widths (ns = 10 °s) and high peak power (MW = 106 W). The QS Operating Mode in the SINON is used for the removal of tattoos and treatment of pigmented lesions. The second mode is the Free-Running Operating Mode which is used for the removal of hair.

    AI/ML Overview

    The provided text is a 510(k) Summary of Safety and Effectiveness for the WaveLight SINON laser system. It describes the device, its indications for use, and a comparison to predicate devices, but it explicitly states that no performance data is presented. Therefore, I cannot extract the requested information to describe acceptance criteria and the study that proves the device meets those criteria.

    Specifically, the document states:
    "6. Performance Data
    None presented."

    This means that the document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Information on experts or ground truth establishment.
    4. Adjudication methods.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance data.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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