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510(k) Data Aggregation
K Number
K002703Device Name
O-PERM 30
Manufacturer
Date Cleared
2000-11-21
(83 days)
Product Code
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
OPTICAL POLYMER RESEARCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K954124Device Name
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
Manufacturer
Date Cleared
1996-03-19
(200 days)
Product Code
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
OPTICAL POLYMER RESEARCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity.
RGP Toric contact lenses made from 0->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.
Device Description
O->PERM 30A (sterafocon A) is a RGP silicone-acrylate polymer which can be lathed into spherical or toric contact lenses. These hemispherical shells when placed on the eye act as a refracting medium to focus light rays on the retina.
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