# K061157: Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb
- Decided: Jun 22, 2006 after 57 days
- Product code: MVN (Lens, Contact, (Disposable))
- 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: 3 generations back to K974780 (1998). 4 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 14 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.
- K011718: Bausch & Lomb Soflens One Day Disposable (Hilafilcon a) Visibility Tinted Contact, Bausch & Lomb, Inc. (2001) Summary page 1.
- K994125: Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses, Bausch & Lomb, Inc. (2000) Summary page 1.

## Most influential descendants
- 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
- K143632: Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens (2015), 1 descendant of its own

## Indications for use
The SofLens® daily disposable (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 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. 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/K061157
Methodology: https://510kreport.com/methodology