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510(k) Data Aggregation

    K Number
    K160472
    Device Name
    Hidrocor, Hidrocharme, and Natural Colors
    Manufacturer
    Date Cleared
    2016-08-10

    (173 days)

    Product Code
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLOTICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hidrocor, Hidrocharme, and Natural Colors Soft (hydrophilic) Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye, including ocular masking, either in sighted eyes that require a prosthetic contact lens for the cosmetic management of conditions such as scleral, corneal, iris, or lens abnormalities. Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients. Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
    Device Description
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