510(k) · Cleared
ClearedAcuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vistakon, Johnson & Johnson Vision Products, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 23, 2000 as substantially equivalent to K991134 (Vistakon, Johnson & Johnson Vision Products, Inc., 1999) after a 63-day review. Its family tree reaches back 2 generations to 1996. 17 later devices descend from it.
- Decided
- Feb 23, 2000
- Review
- 63 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K962804 (1996). 17 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 1 generation backK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- This deviceK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
- Descendant · cites it directly · 16 of its ownK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
- Descendant · 2 generations on · 14 of its ownK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 7 of its ownK062614 Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and…Johnson & Johnson Vision Care, Inc. · 2006 · Recalled
- Descendant · 4 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
- Descendant · 3 generations on · 3 of its ownK141917 Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker…Unicon Optical Co., Ltd. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K013973Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted…Vistakon · 2002 · cites it directly16descendants
- K051900Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for…Johnson & Johnson Vision Care, Inc. · 2005 · 2 generations on14descendants
- K062614Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility…Johnson & Johnson Vision Care, Inc. · 2006 · 3 generations on7descendants
- K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 4 generations on4descendants
- K141917Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily WearUnicon Optical Co., Ltd. · 2014 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −1 | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| 0 (this device) | K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
| +1 | K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted… | Vistakon | 2002 | — |
| +2 | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV… | Johnson & Johnson Vision Care, Inc. | 2005 | 2 |
| +3 | K062614 | Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted… | Johnson & Johnson Vision Care, Inc. | 2006 | 3 |
| +4 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact… | Pegavision Corporation | 2020 | — |
| +3 | K141917 | Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily… | Unicon Optical Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with…Summary page 1…dicate The predicate device is ACUVUE (etafilcon A) soft (hydrophilic) contact devices lenses, clear and visibility tinted, with UV blocker, for daily wear covered under K991134. Description of The device description does not change from that cleared under K991134. device Continued on next page === Pag… | 1999 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted… | 2002 | 16 |
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?
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 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 (205 words)
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 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 10.00 D of astigmatism or less.
ACUVUE 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/K994324 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994324: Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted 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/K994324
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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