# K992446: Dailies (Nelfilcon a) One-Day

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Johns Creek Mfg.
- Decided: Aug 18, 1999 after 27 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: 2 generations back to P820021 (1983). 4 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963487: Dailies (Nelfilcon a) One-Day Soft Contact Lens, Ciba Vision Corporation (1996). Our OCR of the scanned summary read K943487, FDA’s number for BIO74-PF Crown & Bridge Alloy (Jeneric/Pentron, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CIBA Vision's Focus® DAILIES® (nelfilcon A) One-Day Contact Lens —…”. Summary page 2.
- K984273: Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens, Ciba Vision Corporation (1999) Summary page 1.

## Most influential descendants
- K050213: Freshlook One-Day Color Contact Lens (2005), 21 descendants of its own
- K083216: Ciba Vision (Nelfilcon a) One-Day Soft Contact Lenses (2009), 10 descendants of its own
- K123484: Saview-Colors 42 UV (Hefilcon a) ,Toric (Hefilcon a), Multifocal (Hefilcon a)Soft (Hydrophilic) Contact Lens (2013), 8 descendants of its own
- K162317: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (2016), 7 descendants of its own
- K153643: Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives (2016), 7 descendants of its own

## Indications for use
The Focus® DAILIES® (nelfilcon A) One-Day contact lens is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not aphakic persons with non-diseased eyes. Eye care practitioners may prescribe the lens for single-use daily disposable wear. DAILIES (nelfilcon A) lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K992446
Methodology: https://510kreport.com/methodology