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510(k) Data Aggregation

    K Number
    K992950
    Device Name
    CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS
    Manufacturer
    PROSTHETIC SOFT LENS CORP.
    Date Cleared
    1999-11-18

    (78 days)

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

    PROSTHETIC SOFT LENS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eve. including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.
    Device Description
    The Prosthetic (hefilcon A)Soft Lens is a partially or totally white opaque lens that is painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The approved pigment, titanium dioxide, is incorporated into the lens matrix as the white opaquing agent. Lenses are printed or painted by skilled artists to a eye care practitioners specifications with approved reactive dyes. The opaquing agent and colorants are permanent and are not leached from a lens.
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