# K963487: Dailies (Nelfilcon a) One-Day Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Nov 27, 1996 after 85 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P820021 (1983). 2 ancestors in all.
26 later devices descend from it; 6 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P820021: Softcon (Vifilcon a) Soft Contact Ext Wear Lens, Alcon Laboratories, Inc. (1983) Summary page 1.
- P890029: Excelens (Atlafilcon a) Contact Lens, Ciba Vision Corporation (1989) Summary page 1.

## Most influential descendants
- K992446: Dailies (Nelfilcon a) One-Day (1999), 22 descendants of its own
- K050213: Freshlook One-Day Color Contact Lens (2005), 21 descendants of its own
- K033701: Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives One-Day Soft Contact Lenses (2003), 12 descendants of its own
- K050065: Focus Dailies, Focus Dailies Toric and Focus Dailies Progressives (2005), 11 descendants of its own
- K083216: Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses (2009), 10 descendants of its own

## Recalls of this device
- May 6, 2003 · Not classified · Z-0827-03: Lenses may be labeled with the incorrect axis.

## Indications for use
DAILIES™ (nelfilcon A) ONE-DAY CONTACT LENSES are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in non-aphakic persons with non-diseased eyes. DAILIES™ (neifilcon A) ONE-DAY CONTACT LENSES are to be prescribed for single use Daily Disposable Wear. DAILIES™ lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K963487
Methodology: https://510kreport.com/methodology