# K200528: Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism

- Pathway: 510(k) (Traditional)
- Applicant: Bausch + Lomb, Incorporated
- Decided: Jun 2, 2020 after 92 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 K974780 (1998). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113703: Bausch + Lomb Nesofilcon a Contact Lens, Bausch & Lomb, Incorporated (2012) Summary page 4.

## Most influential descendants
- K210975: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (2021), 1 descendant of its own
- K220613: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (2023), 0 descendants of its own

## Indications for use
Kalifilcon A Contact Lens Bausch + Lomb kalifilcon A Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D. Kalifilcon A Contact Lens for Astigmatism Bausch + Lomb kalifilcon A Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters. The lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.

Source page: https://510kreport.com/device/K200528
Methodology: https://510kreport.com/methodology