# K160609: AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: May 2, 2016 after 60 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)
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs, Ciba Vision Corporation (2004) Summary page 4.
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses, Ciba Vision Corporation (2008) Summary page 4.

## Indications for use
Lotrafilcon B spherical soft contact lenses are indicated 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. Lotrafilcon B toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D) or less of astigmatism. Lotrafilcon B multifocal 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. Lotrafilcon B multifocal toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and presbyopia in phakic or aphakic persons with non-diseased eyes and up to 6.00 diopters (D) or less of refractive and/or corneal astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear (lenses are discarded upon removal from the eye) or daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion and frequent replacement, as recommended by the eye care professional.

Source page: https://510kreport.com/device/K160609
Methodology: https://510kreport.com/methodology