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510(k) Data Aggregation
K Number
K080632Device Name
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
Manufacturer
CLEARLAB SG PTE LTD.
Date Cleared
2008-10-15
(224 days)
Product Code
MVN, LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
CLEARLAB SG PTE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.
Device Description
The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibilityhandling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name,
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a coloriess, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:
Refractive Index at 21ºC: 1.4011(wet)
Light Transmission: > 95%
Surface Character: Hydrophilic
Water Content at 21ºC: 59.77 %
Specific Gravity at 21ºC: 1.086(wet)
Oxygen Permeability at 34-36°C: 25.38 x 10-11(cm2/sec) (ml O2/ml x mm Hg), (revised Fatt method).
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