510(k) Report

510(k) · Cleared

Cleared

Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker

K083288510(k) TraditionalCleared Sep 3, 2009300-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 Sep 3, 2009 as substantially equivalent to K051129 (Innova Vision, Inc., 2005) and 1 other predicate after a 300-day review. Its family tree reaches back 2 generations to 1996. 13 later devices descend from it.

Decided
Sep 3, 2009
Review
300 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K962804 (1996). 3 ancestors in all. 13 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2023: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant 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 clearedK962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 1996K051129 · Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K051129 · Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 2005K962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 19960+5
  1. Root · 2 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
  2. 1 generation backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
  3. This deviceK083288 Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
  4. Descendant · cites it directly · 10 of its ownK120028 Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012
  5. Descendant · 2 generations on · 6 of its ownK161739 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily…Pegavision Corporation · 2016
  6. Descendant · 3 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
  7. Descendant · 4 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021
  8. Descendant · 2 generations on · 2 of its ownK140025 Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic)…Pegavision Corporation · 2014

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 12016: 12017: 12018: 12020: 12021: 12022: 12023: 12024: 22026: 1
2012high 2 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 13 · See all
  • K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012 · cites it directly10descendants
  • K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…Pegavision Corporation · 2016 · 2 generations on6descendants
  • K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 3 generations on4descendants
  • K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 4 generations on2descendants
  • K140025Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2014 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerVistakon, Johnson & Johnson Vision Products, Inc.1996—
−1K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.2005—
0 (this device)K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc.2009—
+1K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation2012—
+2K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable…Pegavision Corporation2016—
+3K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation2020—
+4K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2021—
+2K140025Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201510
201610
201710
201810
202010
202110
202210
202310
202420
202610
FIG. 1 — Lineage of K083288, 1996–2026Source: 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
*K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear
Summary page 1
…. FDA Classification: Class I Predicate Device: Discon (Etafilcon A) Soft (hydrophilic) Contact ACUVUE (Etafilcon A) Contact Lens clear Lens for Daily Wear cleared via K051129 and visibility tint with UV blocker cleared , INNOVA VISION INC. Taiwan via K962804 Vistakon, USA Indications for Use Discon Plu…
Innova Vision, Inc.2005—
*K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker
Summary page 1
…lic) Contact ACUVUE (Etafilcon A) Contact Lens clear Lens for Daily Wear cleared via K051129 and visibility tint with UV blocker cleared , INNOVA VISION INC. Taiwan via K962804 Vistakon, USA Indications for Use Discon Plus (Etafiicon A) Contact Lens visibility tint with UV blocker is indicated for dally…
Vistakon, Johnson & Johnson Vision Products, Inc.1996—

Also cleared against K051129: 2 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation201210
K222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensInnova Vision, Inc.20231

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?

  • The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K120028 (Pegavision Corporation, 2012) has gone furthest, with 10 descendants of its own.
  • 2 other devices also cite its predicate K051129.

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. 2009, this device’s year, is highlighted.

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?

Discon Plus (Etafilcon A) Contact Lens visibility tint with UV blocker is indicated for daily wear for the correction of refractive ametropia 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 eyecare professional. When prescribed for frequent/planned replacement wear. The contact lens may be disinfected using chemical (not heat) disinfection system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K051129

2 other devices cite the same predicate.

  • K062541Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2007
  • K053191Discon Daily (Etafilcon a) One-Day Soft (Hydrophilic) Contact LensInnova Vision, Inc. · 2006

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/K083288 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083288: Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083288

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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