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510(k) Data Aggregation

    K Number
    K990075
    Device Name
    LPULSA SYL-9000 OPHTHALMIC YAG LASER
    Manufacturer
    LIGHT-MED (USA), INC.
    Date Cleared
    1999-03-30

    (78 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LPULSA SYL-9000 OPHTHALMIC YAG LASER

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

    Posterior Capsulotomy Pupillary Membranectomy

    Device Description

    LPULSA SYL-9000 Ophthalmic YAG Laser

    AI/ML Overview

    I apologize, but this document is a 510(k) clearance letter from the FDA for a medical device called the "LPULSA SYL-9000 Ophthalmic YAG Laser." This type of document confirms that the device is "substantially equivalent" to a legally marketed predicate device and can therefore be marketed.

    While it specifies the "Indications for Use" (Posterior Capsulotomy and Pupillary Membranectomy), it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the efficacy or performance studies that typically involve the questions you've asked. Such details are usually found in the 510(k) submission itself or in separate clinical study reports, which are not part of this clearance letter.

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

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