# K050213: Freshlook One-Day Color Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Mar 28, 2005 after 56 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: 3 generations back to P820021 (1983). 8 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 30 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 reading of the summary gave 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 3.
- K984273: Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens, Ciba Vision Corporation (1999) Summary page 1.
- K010636: Focus Dailies (Nelfilcon a) One-Day Soft Contact Lenses, Focus Dailies Progressives (Nelfilcon a) One-Day Soft Contact, Ciba Vision Corporation (2001) Summary page 1.
- K003826: Focus Dailies Progressives, Ciba Vision Corporation (2001) Summary page 1.
- K992446: Dailies (Nelfilcon a) One-Day, Ciba Vision Johns Creek Mfg. (1999) Summary page 3.
- P830037: Durasoft (R) 3 for Ext Wear, Alcon Laboratories, Inc. (1984) Summary page 1.

## Most influential descendants
- 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
- K200296: Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (2020), 4 descendants of its own

## Indications for use
FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye. FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye. The FreshLook® (nelfilcon A) One Day Color Contact Lenses are to be prescribed for single-use Daily Disposable Wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use.

Source page: https://510kreport.com/device/K050213
Methodology: https://510kreport.com/methodology