510(k) · Cleared

Cleared

Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear

K051129510(k) TraditionalCleared Aug 12, 2005101-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 Aug 12, 2005 as substantially equivalent to K033136 (Innova Vision, Inc., 2004) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 1996. 18 later devices descend from it.

Decided: Aug 12, 2005
Review: 101 days
Class: Class II
Product code: LPL
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K962804 (1996). 2 ancestors in all. 18 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
This deviceK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
Descendant · cites it directly · 13 of its ownK083288 Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
Descendant · 2 generations on · 10 of its ownK120028 Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012
Descendant · 3 generations on · 6 of its ownK161739 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily…Pegavision Corporation · 2016
Descendant · 4 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
Descendant · 5 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 18 · See all

K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009 · cites it directly13descendants
K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012 · 2 generations on10descendants
K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…Pegavision Corporation · 2016 · 3 generations on6descendants
K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 4 generations on4descendants
K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962804	Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker	Vistakon, Johnson & Johnson Vision Products, Inc.	1996	—
0 (this device)	K051129	Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	Innova Vision, Inc.	2005	—
+1	K083288	Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker	Innova Vision, Inc.	2009	—
+2	K120028	Aquamax (Etafilcon a) Disposable Soft Contact Lenses	Pegavision Corporation	2012	—
+3	K161739	Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable…	Pegavision Corporation	2016	—
+4	K200296	Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact…	Pegavision Corporation	2020	—
+5	K211448	Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses…	Pegavision Corporation	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2009	1	0
2012	2	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2020	1	0
2021	1	0
2022	1	0
2023	1	0
2024	2	0
2026	1	0

FIG. 1 — Lineage of K051129, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K033136	I-Lux Innova Blue Tint Lens, Model Super O2 Summary page 1 …Registration Number 3003746024 PredictDevice: SuperView (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K033136)-made from Innova Vision Inc., Taiwan. ACUVUE (etafilcon A) Contact Lens Vi…	Innova Vision, Inc.	2004	—
*	K962804	Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker Summary page 1 …made from Innova Vision Inc., Taiwan. ACUVUE (etafilcon A) Contact Lens Visibility tint (K962804) -made from Johnson & Johnson Co. USA. IndicationsforUse: Discon (Etafilcon A)Soft (hydrophilic) Contact Lens for Daily Wear…	Vistakon, Johnson & Johnson Vision Products, Inc.	1996	—

Also cleared against K033136: 1 other device →

What descends from it? (18)

See all 18

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

Number	Device	Applicant	Decided	Descendants
K083288	Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker	Innova Vision, Inc.	2009	13
K062541	Calaview Colors (Etafilcon a) Soft (Hydrophilic) Contact Lens	Innova Vision, Inc.	2007	2
K053191	Discon Daily (Etafilcon a) One-Day Soft (Hydrophilic) Contact Lens	Innova Vision, Inc.	2006	0

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?

None of the 2 ancestors has a recall.
Of its descendants, K083288 (Innova Vision, Inc., 2009) has gone furthest, with 13 descendants of its own.
1 other device also cites its predicate K033136.

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

2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007high 281 (2007) · low 56 (2018)2026

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

Recalls per year · LPL

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	281	1	280
2008	10	104	0	214
2009	6	260	1	137
2010	9	244	0	222
2011	12	170	5	377
2012	12	131	1	250
2013	17	135	0	151
2014	15	102	1	179
2015	12	120	1	161
2016	21	112	0	193
2017	9	98	11	280
2018	21	56	0	257
2019	11	115	0	205
2020	10	158	1	117
2021	8	88	0	110
2022	9	212	1	126
2023	10	167	0	178
2024	12	128	0	297
2025	12	202	1	216
2026	10	90	1	—

What is it indicated for?

Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopia or hyperopia and may exhibited 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 a chemical (not heat) disinfection system only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051129 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051129: Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051129

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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