# K062541: Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Innova Vision, Inc.
- Decided: Jun 7, 2007 after 281 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 K962804 (1996). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010114: Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color), Johnson & Johnson Vision Care, Inc. (2001) Summary page 1.
- K051129: Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Innova Vision, Inc. (2005) Summary page 1.

## Most influential descendants
- K073060: Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear (2007), 1 descendant of its own
- K112373: Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear Modification (2012), 0 descendants of its own

## Indications for use
Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear 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. The eye care practitioner 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/K062541
Methodology: https://510kreport.com/methodology