# K020139: Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Apr 9, 2002 after 83 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: 2 generations back to P810005 (1981). 4 ancestors in all.
95 later devices descend from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970746: SEE3 (Lotrafilcon a) Soft Contact Lens, Ciba Vision Corporation (1997) Summary page 1.
- P010019: Focus Night and Day (Lotrafilcon a) Soft Contact Lenses, Alcon Laboratories, Inc. (2001) Summary page 1.

## Most influential descendants
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs (2004), 94 descendants of its own
- K052560: Biofinity (Comfilcon a) Soft Contact Lens (2005), 74 descendants of its own
- K100221: INTELLIWAVE3 (2010), 32 descendants of its own
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses (2008), 17 descendants of its own
- K071736: Aquair (Enfilcon a) Soft (Hydrophilic) Contact Lens (2008), 14 descendants of its own

## Indications for use
Focus® Excelens™ (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. Focus® Excelens™ 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. Focus® Excelens™ Progressives (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. 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.

Source page: https://510kreport.com/device/K020139
Methodology: https://510kreport.com/methodology