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510(k) Data Aggregation

    K Number
    K013402
    Device Name
    VISULAS 532S
    Manufacturer
    CARL ZEISS, INC.
    Date Cleared
    2001-11-14

    (30 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K925642
    Why did this record match?
    Reference Devices :

    K925642

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

    The VISULAS 532s laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary, delivery or intraocular endoprobe delivery.

    Device Description

    The VISULAS 532s laser represents an improved version of the predicate Zeiss-Diode Pumped Solid State Laser (K925642). The improvement includes the following 2 modifications: In addition to the known laser slit lamp, the slit lamp adapter VISULINK 532/U or the Laser Indirect Ophthalmoscope LIO 532 may be used now as a laser application system. Laser console and user interface were improved to allow operation, setting, and monitoring of the different laser treatment procedures.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of medical device validation for AI-powered diagnostic tools. Instead, the document describes a special 510(k) premarket notification for a modification to an existing ophthalmic surgical laser, the VISULAS 532s.

    The key points from the document are:

    • Device: VISULAS 532s, an ophthalmic surgical laser.
    • Modification: Improvements to the predicate device (Zeiss-Diode Pumped Solid State Laser (K925642)) include:
      • Addition of new laser application systems: VISULINK 532/U (slit lamp adapter) or LIO 532 (Laser Indirect Ophthalmoscope).
      • Improved laser console and user interface for operation, setting, and monitoring.
    • Conclusion: The FDA determined the modified device (VISULAS 532s) is substantially equivalent to the predicate device based on side-by-side comparisons. The modifications do not raise new questions for safety and efficacy.

    Therefore, the specific questions regarding acceptance criteria, reported device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for a diagnostic or AI-powered device are not applicable to the content provided for this surgical laser modification.

    The FDA's substantial equivalence determination for this device modification primarily relies on the comparison to the predicate device, demonstrating that the changes do not alter the fundamental safety or effectiveness of the product for its intended use. There is no mention of analytical or clinical performance studies with acceptance criteria in the context of AI or diagnostic accuracy.

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