# K082883: Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily Wear

- 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 K960926 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020927: Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens, Bausch & Lomb (2002) Summary page 1.
- K033136: I-Lux Innova Blue Tint Lens, Model Super O2, Innova Vision, Inc. (2004) Summary page 1.
- (no number) Optima FW (polymacon) Visibility Tinted Contact Lenses: named in the summary without a submission number

## Most influential descendants
- K151847: SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens (2016), 0 descendants of its own

## Indications for use
EZvue (Polymacon) 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 frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.

Source page: https://510kreport.com/device/K082883
Methodology: https://510kreport.com/methodology