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Found 5 results
510(k) Data Aggregation
K Number
K011945Device Name
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
Manufacturer
POLYMER TECHNOLOGY CORP.
Date Cleared
2001-09-12
(83 days)
Product Code
HQD
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) RGP Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
Device Description
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Contact Lenses are composed of fluoro silicone acrylate copolymers wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.
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K Number
K980133Device Name
BAUSCH & LOMB WETTING AND SOAKING SOLUTION
Manufacturer
POLYMER TECHNOLOGY CORP.
Date Cleared
1998-03-11
(55 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BAUSCH & LOMB® Wetting and Soaking Solution is indicated for use in disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.
Device Description
BAUSCH & LOMB Wetting and Soaking Solution is a sterile conditioning solution used in the care of rigid gas permeable and hard (PMMA) contact lenses and is indicated for the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses. This product is contained in a plastic bottle, and consists of a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.
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K Number
K974466Device Name
BOSTON ADVANCE CLEANER
Manufacturer
POLYMER TECHNOLOGY CORP.
Date Cleared
1998-02-19
(85 days)
Product Code
MRC
Regulation Number
886.5918Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Boston Advance ® Cleaner is indicated for use to clean fluoro silicone and silicone acrylate rigid gas permeable contact lenses after each removal and before conditioning (wetting, soaking, and disinfecting).
Device Description
Boston Advance® Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alky ether sulfate, ether sulfate, ethoxylated alkyl phenol, triquaternary cocoabased phospholipid, silica gel as cleaning agents; with titanium dioxide.
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K Number
K973217Device Name
BOSTON LIQUID ENZYMATIC CLEANER
Manufacturer
POLYMER TECHNOLOGY CORP.
Date Cleared
1997-11-24
(89 days)
Product Code
LPN
Regulation Number
886.5928Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Boston® Liquid Enzymatic Cleaner is indicated for weekly enzymatic cleaning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses during simultaneous conditioning (wetting, soaking, and disinfecting) with Original Formula Boston® Conditioning Solution, Boston ADVANCE® Comfort Formula Conditioning Solution, or Boston SIMPLICITY® Multi-Action Solution.
Device Description
The Boston® Liquid Enzymatic Cleaner is a sterile, aqueous, buffered solution containing proteolytic enzyme (subtilisin) as the cleaning agent, and glycerol. Preservative-free.
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K Number
K970698Device Name
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
Manufacturer
POLYMER TECHNOLOGY CORP.
Date Cleared
1997-05-06
(70 days)
Product Code
HQD
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
POLYMER TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with nondiseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only
Device Description
The BOSTON ES MULTIVISION (enflufocon A) is an aspheric multifocal rigid gas permeable, fluoro silicone acrylate contact lens for daily wear. The BOSTON ES MULTIVISION (enflufocon A) contact lens provides distance and near vision through the use of its back surface design. The central portion of the lens provides the distance vision; the mid-peripheral portion provides the near vision and the far peripheral portion provides the fitting performance of the lens. The aspheric design is a series of ever increasing radius curves from the center of the lens to the periphery which provides the ' add' power for central ellipse for distance vision, a hyperbolic curve in the midperiphery for the near vision, and a fillet and steeper hyperbolic design in the periphery for the fitting design.
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