510(k) · Cleared

Cleared

Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear

K991134510(k) TraditionalCleared May 6, 199934-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

Vistakon, Johnson & Johnson Vision Products, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on May 6, 1999 as substantially equivalent to K962804 (Vistakon, Johnson & Johnson Vision Products, Inc., 1996) after a 34-day review. Its family tree reaches back 1 generation to 1996. 20 later devices descend from it.

Decided: May 6, 1999
Review: 34 days
Class: Class II
Product code: LPL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962804 (1996). 20 later devices descend from it, 2 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 deviceK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
Descendant · cites it directly · 17 of its ownK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
Descendant · 2 generations on · 16 of its ownK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
Descendant · 3 generations on · 14 of its ownK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005 · Recalled
Descendant · 4 generations on · 7 of its ownK062614 Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and…Johnson & Johnson Vision Care, Inc. · 2006 · Recalled
Descendant · cites it directly · 6 of its ownK161739 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily…Pegavision Corporation · 2016

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2000high 2 (2006) · low 0 (2001)2026

Most influential descendants

Showing 5 of 20 · See all

K994324Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000 · cites it directly17descendants
K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Vistakon · 2002 · 2 generations on16descendants
K051900Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for…Johnson & Johnson Vision Care, Inc. · 2005 · 3 generations on14descendants
K062614Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility…Johnson & Johnson Vision Care, Inc. · 2006 · 4 generations on7descendants
K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…Pegavision Corporation · 2016 · cites it directly6descendants

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)	K991134	Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility…	Vistakon, Johnson & Johnson Vision Products, Inc.	1999	—
+1	K994324	Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility…	Vistakon, Johnson & Johnson Vision Products, Inc.	2000	—
+2	K013973	Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…	Vistakon	2002	—
+3	K051900	Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV…	Johnson & Johnson Vision Care, Inc.	2005	2
+4	K062614	Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted…	Johnson & Johnson Vision Care, Inc.	2006	3
+1	K161739	Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable…	Pegavision Corporation	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2005	1	0
2006	2	0
2014	2	0
2015	1	0
2016	1	0
2017	2	0
2018	1	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K991134, 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K962804	Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker Summary page 1 …redicate The predicate device is ACUVUE (etafilcon A) soft (hydrophilic) contact devices lenses, clear and visibility tint, with UV blocker, for daily wear covered under K962804. Description of The device description does not change from that cleared under K962804. device Continued on next page === Pag…	Vistakon, Johnson & Johnson Vision Products, Inc.	1996	—

Also cleared against K962804: 11 other devices →

What descends from it? (20)

See all 20

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

Number	Device	Applicant	Decided	Descendants
K994324	Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV…	Vistakon, Johnson & Johnson Vision Products, Inc.	2000	17
K161739	Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…	Pegavision Corporation	2016	6

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?

Its one ancestor has no recall.
Of its descendants, K994324 (Vistakon, Johnson & Johnson Vision Products, Inc., 2000) has gone furthest, with 17 descendants of its own.
11 other devices also cite its predicate K962804.

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?

The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The ACUVUE BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism. The…

Read the full statement (207 words)

The ACUVUE BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism.

The ACUVUE TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism.

The ACUVUE TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.

ACUVUE UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye care practitioners may prescribe the lens for either single-use disposable wear or for frequent/ planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.

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

https://510kreport.com/device/K991134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991134: Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, 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/K991134

Report an extraction error

Are you the manufacturer?

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