# K222500: Air Optix Colors

- Pathway: 510(k) (Special)
- Applicant: Alcon Laboratories, Inc.
- Decided: Sep 15, 2022 after 28 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172600: AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal, Alcon Laboratories, Inc. (2017) Summary page 4.

## Indications for use
AIR OPTIX® COLORS (lotrafilcon B) spherical soft contact lenses with refractive power are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. AIR OPTIX® COLORS (lotrafilcon B) toric soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism. AIR OPTIX® COLORS (lotrafilcon B) multifocal soft contact lenses are indicated for daily wear 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. AIR OPTIX® COLORS (lotrafilcon B) lenses with or without refractive power act to enhance or alter the apparent color of the eye. The lenses may be prescribed for frequent/planned replacement wear with daily removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.

Source page: https://510kreport.com/device/K222500
Methodology: https://510kreport.com/methodology