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510(k) Data Aggregation

    K Number
    K201013
    Device Name
    Optixon 1-Day
    Manufacturer
    Date Cleared
    2020-09-18

    (154 days)

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

    Optixon Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OPTIXON I- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
    Device Description
    OPTIXON 1- DAY (omafilcon A)is daily disposable soft contact lenses(single use) produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine) The contact lenses contain 59% water by weight and is sold in the blister package immersed in packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens. The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve). The contact lenses are hydrophilic, soft and it is supplied in sterile state.
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