# 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

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Mar 8, 2023 after 370 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: 7 generations back to K974780 (1998). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200528: Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism, Bausch + Lomb, Incorporated (2020) Summary page 4.
- K210975: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Bausch & Lomb, Incorporated (2021) Summary page 4.

## Indications for use
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) 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 maybe prescribed in spherical powers ranging from +20.00D to -20.00D. Bausch + Lomb (kalifilcon A) Soft (hydrophilic) 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. Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting 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 with add powers ranging from +0.75D to +5.00D. 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/K220613
Methodology: https://510kreport.com/methodology