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510(k) Data Aggregation
K Number
K122315Device Name
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
Manufacturer
Date Cleared
2013-02-15
(198 days)
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
OCULUS PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professionals should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Device Description
Soft (hydrophilic) contact lens
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K Number
K103132Device Name
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
Manufacturer
Date Cleared
2011-09-08
(318 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
OCULUS PRIVATE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FreshKon® (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be used to enhance or alter the apparent color of the eye. The lenses may be disinfected using a chemical disinfection system.
Device Description
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