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510(k) Data Aggregation
K Number
K020193Device Name
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
Manufacturer
CL MCINTOSH
Date Cleared
2002-02-28
(41 days)
Product Code
LPL, MVN
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
CL MCINTOSH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes which manifest myopia (nearsightedness), hyperopia (farsightedness) and astigmatic correction lower than -2.00 diopters that does not interfere with visual acuity.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses may be prescribed for daily wear. The eye-care practitioner may prescribe the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) contact lenses for single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for scheduled replacement the lens may be disinfected using a chemical (no heat) or hydrogen peroxide disinfecting systems.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Device Description
BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):
- plano to -10.00D Asphere .
- . with center thickness from 0.025mm to 0.40mm
- . with base curves of 8.00mm to 9.20mm
- . with diameter of 12.00mm to 18.00mm
The lens material is the same as the one BIOMEDICS® UV described in submission PMA890023/S4 and S7, K982947, K984046, K012425.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum cage thickness and This front optical surface allows for correction of visual acuity in non-aphakic persons with noncontour. diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range.
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