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510(k) Data Aggregation

    K Number
    K252175

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-10

    (214 days)

    Product Code
    Regulation Number
    886.5928
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LANDR Contact Lens Case is designed for storing soft (hydrophilic), rigid gas-permeable, and/or rigid contact lenses. It is only for use during storage with chemical disinfection and should not be used during heat disinfection.

    Device Description

    The LANDR Lens Case has dual-sided storage compartments (one per lens) stacked together (Figure 1). The case uses a ball plunger to hold the detachable cases together in one piece during shipping. Each compartment is colored to differentiate the cases.

    The individual cases should be separated by pulling them apart and placing them on a flat surface right side up before use (Figure 2). When disinfecting and storing contact lenses, each case must be kept upright on a flat surface in the correct orientation (Figure 2) with the lids securely closed.

    AI/ML Overview

    N/A

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