# K052560: Biofinity (Comfilcon a) Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Dec 6, 2005 after 81 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P810005 (1981). 6 ancestors in all.
74 later devices descend from it; 15 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970746: SEE3 (Lotrafilcon a) Soft Contact Lens, Ciba Vision Corporation (1997) Summary page 2.
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs, Ciba Vision Corporation (2004) Summary page 2.

## Most influential descendants
- K100221: INTELLIWAVE3 (2010), 32 descendants of its own
- K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens (2008), 14 descendants of its own
- K141348: Visco Soft Contact Lens (2015), 12 descendants of its own
- K142641: Intelliwave4 (2015), 12 descendants of its own
- K152046: Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) (2015), 11 descendants of its own

## Recalls of this device
- Sep 1, 2017 · Class III · Z-0691-2018: The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric.

## Indications for use
SPHERICAL AND ASPHERICAL: BIOFINITY (comfilcon A) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. TORIC: BIOFINITY (comfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. MULTIFOCAL: BIOFINITY (comfilcon A) multifocal lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The BIOFINITY (comfilcon A), BIOFINITY Toric (comfilcon A) and BIOFINITY Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Source page: https://510kreport.com/device/K052560
Methodology: https://510kreport.com/methodology