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510(k) Data Aggregation
K Number
K142820Device Name
BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear
Manufacturer
Date Cleared
2015-04-30
(212 days)
Product Code
Regulation Number
886.5925Why did this record match?
Applicant Name (Manufacturer) :
ABB Optical Group, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +20.00 to -20.00 D.
The BIOLENS Toric (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +20.00 to -20.00 D and a cylinder power range up to -10.0D.
The BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +20.00 to -20.00 D and have near add requirements up to 3.25 D.
The BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +20.00 to -20.00 D, a cylinder power range up to -4.00 D and an add requirement up to +3.25 D.
BIOLENS lenses may be disinfected using chemical (not heat) disinfecting systems.
BIOLENS UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Device Description
The BIOLENS (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is available in spherical, toric, multifocal, and toric-multifocal designs. Specifically, the BIOLENS models are hemispheric flexible shells of the following parameters:
Diameter(s): 12.0 mm to 16.0 mm
Center Thickness (Low Minus Lens): 0.07 mm dry
Center Thickness (Plus Lens): Up to 0.50 mm
Base Curve(s): 8.0 mm - 9.5 mm
Powers: -20.00 D to +20.00 D
Cylinder Powers: Not Applicable (N/A) for Sphere and Multifocal; Up to -10.00 D in steps of 0.25 D for Toric; Up to -4.00 D in steps of 0.25 D for Toric Multifocal
Axis: Not Applicable (N/A) for Sphere and Multifocal; 1° to 180° for Toric and Toric Multifocal
Add Powers: N/A for Sphere and Toric; +0.50D to +3.25D for Multifocal and Toric Multifocal
All BIOLENS lenses are plasma treated in the dry state prior to initial hydration.
The lens material (mangofilcon A) is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A and 49% water by weight. Mangofilcon A is available clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). Mangofilcon A is also available in Blue or Aqua visibility tints to assist with handling. Both colors are available with or without the UV absorber.
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