# K142820: 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

- Pathway: 510(k) (Traditional)
- Applicant: Abb Optical Group, LLC
- Decided: Apr 30, 2015 after 212 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K964528 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120756: LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact LE, The Lagado Corp. (2013) Summary page 7.
- K133079: IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric (Mangofilcon a) Soft (Hydrophilic), Alden Optical Labs., Inc. (2013) Summary page 7.

## Indications for 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.

Source page: https://510kreport.com/device/K142820
Methodology: https://510kreport.com/methodology