# K133176: Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Jan 29, 2014 after 104 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). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses, Ciba Vision Corporation (2008) Summary page 1.
- P830037: Durasoft (R) 3 for Ext Wear, Alcon Laboratories, Inc. (1984) Summary page 1.

## Most influential descendants
- K172600: AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal (2017), 1 descendant of its own
- K222500: Air Optix Colors (2022), 0 descendants of its own

## Indications for use
AIR OPTiX® COLORS (lotrafilcon B) spherical 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 and with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. AIR OPTIX® COLORS Toric (lotrafilcon B) 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 Multifocal (lotrafilcon B) soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia 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/K133176
Methodology: https://510kreport.com/methodology