# K112373: Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear Modification

- Pathway: 510(k) (Traditional)
- Applicant: Innova Vision, Inc.
- Decided: Aug 17, 2012 after 366 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: 4 generations back to K962804 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073060: Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Innova Vision, Inc. (2007) Summary page 1.

## Indications for use
Calaview Color (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. Eye care practitioners may prescribe the lenses for either single-use daily disposable wear or frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eve care professional. When prescribed for frequent/planned replacement wear, the contact lens may be disinfected using chemical (not heat) disinfection system.

Source page: https://510kreport.com/device/K112373
Methodology: https://510kreport.com/methodology