# K033136: I-Lux Innova Blue Tint Lens, Model Super O2

- Pathway: 510(k) (Traditional)
- Applicant: Innova Vision, Inc.
- Decided: Mar 5, 2004 after 157 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
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Optima FW (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087): named in the summary without a submission number
- (no number) SeeQuence (polymacon) Contact Lens for Daily Wear: named in the summary without a submission number

## Most influential descendants
- K051129: Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear (2005), 18 descendants of its own
- K083288: Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker (2009), 13 descendants of its own
- K120028: Aquamax (Etafilcon a) Disposable Soft Contact Lenses (2012), 10 descendants of its own
- K161739: Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (2016), 6 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
The SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia (nearsighted) 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. The contact lens may be disinfected using heat (not chemical), hydrogen peroxide, or chemical (not heat) disinfection system.

Source page: https://510kreport.com/device/K033136
Methodology: https://510kreport.com/methodology