# K212806: Alcon (serafilcon A) soft contact lenses for daily wear

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Dec 28, 2021 after 116 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: 5 generations back to P810005 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052560: Biofinity (Comfilcon a) Soft Contact Lens, CooperVision, Inc. (2005) Summary page 5.

## Indications for use
Alcon (serafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Alcon for Astigmatism (serafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have up to 6.00 diopters (D) of astigmatism. Alcon Multifocal (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. Alcon Multifocal Toric (serafilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. The lenses are to be prescribed for daily wear with removal for disposal, or cleaning and disinfection (chemical not heat) prior to reinsertion, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each week, or more often, if recommended by the eye care professional.

Source page: https://510kreport.com/device/K212806
Methodology: https://510kreport.com/methodology