510(k) Report

510(k) · Cleared

Cleared

I-Lux Innova Blue Tint Lens, Model Super O2

K033136510(k) TraditionalCleared Mar 5, 2004157-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Innova Vision, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Mar 5, 2004 after a 157-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.

Decided
Mar 5, 2004
Review
157 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

21 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2005: 1 descendant cleared2007: 2 descendants cleared2006: 1 descendant cleared2016: 2 descendants cleared2023: 1 descendant cleared2012: 2 descendants cleared2014: 1 descendant cleared2024: 2 descendants cleared2015: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK033136 I-Lux Innova Blue Tint Lens, Model Super O2Innova Vision, Inc. · 2004
  2. Descendant · cites it directly · 18 of its ownK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
  3. Descendant · 2 generations on · 13 of its ownK083288 Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
  4. Descendant · 3 generations on · 10 of its ownK120028 Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012
  5. Descendant · 4 generations on · 6 of its ownK161739 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily…Pegavision Corporation · 2016
  6. Descendant · 5 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 22009: 22012: 22014: 12015: 12016: 22017: 12018: 12020: 12021: 12022: 12023: 12024: 22026: 1
2005high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 21 · See all
  • K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005 · cites it directly18descendants
  • K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009 · 2 generations on13descendants
  • K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012 · 3 generations on10descendants
  • K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…Pegavision Corporation · 2016 · 4 generations on6descendants
  • K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033136I-Lux Innova Blue Tint Lens, Model Super O2Innova Vision, Inc.2004—
+1K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.2005—
+2K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc.2009—
+3K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation2012—
+4K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable…Pegavision Corporation2016—
+5K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200720
200920
201220
201410
201510
201620
201710
201810
202010
202110
202210
202310
202420
202610
FIG. 1 — Lineage of K033136, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPL device

  1. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Optima FW (polymacon) Visibility Tinted Contact Lenses (NDA number N16895/S087)
Named without a submission number
—
*—SeeQuence (polymacon) Contact Lens for Daily Wear
Named without a submission number
—

What descends from it? (21)

See all 21

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.200518
K082883Ezview (Polymacon) Soft (Hydrophillic) Contact Lens for Daily WearI-See Vision Technology, Inc.20091

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051129 (Innova Vision, Inc., 2005) has gone furthest, with 18 descendants of its own.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Innova Vision, Inc.

11 FDA decisions under this applicant name. See the company

  • K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensInnova Vision, Inc. · 2024
  • K232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2023
  • K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2023
  • K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2022
  • K112373Calaview Color (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear ModificationInnova Vision, Inc. · 2012

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K033136 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033136: I-Lux Innova Blue Tint Lens, Model Super O2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033136

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026