# K991000: Gentle Touch UV (Netrafilcon a) Soft Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Wesley Jessen Corp.
- Decided: Jun 28, 1999 after 96 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: 1 generation back to P890012 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P890012: Signature Contact Lens, Ciba Vision Corporation (1989) Summary page 3.

## Indications for use
The Gentle Touch UV (netrafilcon A) soft (hydrophilic) contact lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lens is to be disinfected using a recommended chemical (not heat) disinfection system or hydrogen peroxide disinfection system. Gentle Touch UV (netrafilcon A) lenses help to protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K991000
Methodology: https://510kreport.com/methodology