# K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Feb 28, 2008 after 80 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: 4 generations back to P810005 (1981). 6 ancestors in all.
17 later devices descend from it; 9 cite it directly.
0 of 24 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 1.
- K970746: SEE3 (Lotrafilcon a) Soft Contact Lens, Ciba Vision Corporation (1997) Summary page 4.

## Most influential descendants
- K130331: Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (2013), 6 descendants of its own
- K181920: Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (2018), 3 descendants of its own
- K133176: Air Optix Colors, Air Optix Colors Toric, Air Optix Colors Multifocal (2014), 2 descendants of its own
- K130342: Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker (2013), 2 descendants of its own
- K242413: VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (2024), 1 descendant of its own

## Indications for use
CIBA VISION® (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 with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. CIBA VISION® Toric (lotrafilcon B) 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 6.00 diopters (D)or less of astigmatism. CIBA VISION® Multifocal (lotrafilcon B) soft contact lenses are indicated 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. CIBA VISION® Multifocal Toric (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 6.00 diopters (D) or less of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. CIBA VISION® spherical (lotrafilcon 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 and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. CIBA VISION® toric (lotrafilcon 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 10.00 diopters (D)or less of astigmatism. CIBA VISION® multifocal (lotrafilcon A) soft contact lenses are indicated 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. CIBA VISION® multifocal toric (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 10.00 diopters (D) or less of refractive and/or corneal astigmatism. The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional. In addition, CIBA VISION® (lotrafilcon A) lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during healing if required.

Source page: https://510kreport.com/device/K073459
Methodology: https://510kreport.com/methodology