# K994125: Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Mar 3, 2000 after 87 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 K974780 (1998). 2 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974780: Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb, Inc. (1998) Summary page 1.
- K983894: Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb, Inc. (1998) Summary page 1.

## Most influential descendants
- K061157: Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens (2006), 9 descendants of its own
- K113703: Bausch + Lomb Nesofilcon a Contact Lens (2012), 6 descendants of its own
- K132715: Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens (2013), 3 descendants of its own
- K200528: Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism (2020), 2 descendants of its own
- K210975: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (2021), 1 descendant of its own

## Indications for use
The BAUSCH & LOMB® 2 -Week (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D. Replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K994125
Methodology: https://510kreport.com/methodology