# K143632: Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Feb 13, 2015 after 53 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). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 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.
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia,, Bausch & Lomb, Inc. (2013) Summary page 4.

## Most influential descendants
- K151918: Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist (2016), 0 descendants of its own

## Indications for use
The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear. 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/K143632
Methodology: https://510kreport.com/methodology