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510(k) Data Aggregation
K Number
K021752Device Name
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL
Manufacturer
Date Cleared
2002-10-11
(136 days)
Product Code
Regulation Number
886.5916Why did this record match?
Applicant Name (Manufacturer) :
LUCID KOREA CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FP(hexafocon A) and ASP(hexafocon A) RGP Contact Lens are indicated for daily wear for the correction of refractive amptropia (myopia, lyperopia, astigmatism) in aphakic and not- aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
Device Description
FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical(not heat) disinfecting system only.
The FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical are is hemispherical shell of the following dimentions.
· Diameter: 8.00 to 10.00mm
· Center Thickness: 0.10 to 0.50mm
· Base Curve: 6.00 to 9.00mm
· Power: -20.0 to +20.0 diopter
The physical properties of the lens are
- · Specific Gravity 1.27
- · Refractive Index 1.415
- · Light Transmittance 92%
- · Surface Character Hydrophobic
- 490 · Wetting Angle
- · Water Content <1%
- · Hardness(shore D) 81
- 140*(100**) { × 10 + ( cm3 O2 cm ) ( cm2 sec mm Hg ) @ 3 5 ℃ } · Oxygen Permeability
- * gas to gas method
- ** polarographic method(ISO/Fatt)
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