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510(k) Data Aggregation

    K Number
    K110452
    Device Name
    SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
    Manufacturer
    UNILENS CORP., USA
    Date Cleared
    2011-04-20

    (63 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Special
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K940777,K941836,K942372,K942494,K960926,K961428,K965012,K971647,K000529,K002408,K041608,K050743,K082393,K100456
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification decision letter from the FDA to UNILENS Corporation, USA. It concerns the conversion of soft (hydrophilic) daily wear contact lenses to parametric release from moist heat sterilization.

    This document does not contain the information requested regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    The letter acknowledges the submission and clarifies regulatory aspects but does not include the detailed study results or performance metrics one would expect in a clinical study report or verification and validation documentation. It lists numerous previously cleared products and their approval numbers but does not delve into the studies supporting the parametric release change.

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