# K974780: Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Mar 11, 1998 after 79 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
No predicates in its family tree.
12 later devices descend from it; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) BAUSCH & LOMB® SofLens66™ (alphafilcon A) Visibility Tinted Contact Lens: named in the summary without a submission number

## Most influential descendants
- K983894: Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens (1998), 11 descendants of its own
- K994125: Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses (2000), 10 descendants of its own
- 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

## Indications for use
The BAUSCH & LOMB® Soflens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) 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 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/K974780
Methodology: https://510kreport.com/methodology