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510(k) Data Aggregation
K Number
K991015Device Name
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
Manufacturer
LAMDA POLYTECH LTD.
Date Cleared
1999-11-02
(221 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
LAMDA POLYTECH LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LM-70 (lidofilcon A) Spherical Soft Contact Lens for daily wear aisre indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.
The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.
Device Description
The LM-70 Spherical and Toric Soft Contact Lens is fabricated from lidofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (lidofilcon A) soft hydrophilic contact lens has a spherical back 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 warned however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The non-ionic lens material, (lidofilcon A) is a terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA). It consists of 30% lidofilcon A and 70% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 70% water by weight.
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