# K112192: Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Oct 25, 2011 after 88 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: 4 generations back to K974780 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061157: Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens, Bausch & Lomb (2006) Summary page 1.

## Indications for use
The Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and 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/K112192
Methodology: https://510kreport.com/methodology