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510(k) Data Aggregation
K Number
K974408Device Name
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
Manufacturer
BIOCOMPATIBLES EYEWEAR, INC.
Date Cleared
1998-04-16
(143 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES EYEWEAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proclear and Proclear Compatibles (omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement.
Device Description
The Proclear and Proclear Compatibles contact lenses are available as a lathe cut spherical lens, and a molded spherical lens. The lens material (omafilcon A) is a copolymer of 2-hydroxyethy)methacrylate and 2methactyloyloxyethyl phosphorylcholine crosslinked with ethylenestycol dimethacrylate. The Proclear lens with visibility tint is timed blue using Reactive Blue Dye #4 to make the lens more visible for handling.
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K Number
K980218Device Name
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Manufacturer
BIOCOMPATIBLES EYEWEAR, INC.
Date Cleared
1998-03-23
(66 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES EYEWEAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LL-55 (methafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.
Device Description
The LL-55 contact lenses are available as lathe cut spherical lens. The lens material (methafilcon A) is a hydrophilic polymer of hydroxyethylmethacrylate and methacrylic acid.
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K Number
K970095Device Name
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
Manufacturer
BIOCOMPATIBLES EYEWEAR, INC.
Date Cleared
1997-04-03
(83 days)
Product Code
LPL
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES EYEWEAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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