# K082880: Ezvue (Ocufilcon D) 1-Day Soft (Hydrophilic)Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: I-See Vision Technology, Inc.
- Decided: Jun 16, 2009 after 260 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: 2 generations back to K942214 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972303: Oscular Sciences/ American Hydron, Inc  Daily Wear Soft Contact Lens, Ocular Sciences Puerto Rico, Inc. (1997) Summary page 1.

## Indications for use
EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes who may exhibited refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The EZvue (Ocufilcon D) 1-Day Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.

Source page: https://510kreport.com/device/K082880
Methodology: https://510kreport.com/methodology