# K132715: Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Dec 20, 2013 after 112 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). 12 ancestors in all.
3 later devices descend from it; 2 cite 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 1.
- K050948: Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb, Inc. (2005) Summary page 1.

## 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
- 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 Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia, (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power 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/K132715
Methodology: https://510kreport.com/methodology