# K133627: Avaira Spheric and Toric (Enfilcon a) Soft Contact Lens

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Dec 23, 2013 after 27 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: 7 generations back to P810005 (1981). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens, CooperVision, Inc. (2008) Summary page 1.
- K113759: Avaira (Enfilcon a) Contact Lens, CooperVision, Inc. (2012) Summary page 1.

## Indications for use
AVAIRA (enfilcon A) SPHERE Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia and hyperopia) inaphakic 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. AVAIRA (enfilcon A) TOPIC Soil (H-ydrophilic) Contact Lenses are indicated for the correction of visual ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to0+20.00 diopters and astigmatic corrections from -0.25 to -30.00 diopters. The AVAIRA (enfilcan A) Soft (hydrophilic) Contact Lenses are indicated for single-use disposable wear. The AVAIRA (entilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear. When prescribed for planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

Source page: https://510kreport.com/device/K133627
Methodology: https://510kreport.com/methodology