510(k) · Cleared
ClearedAcuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/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 Oct 1, 1996 after a 75-day review. The FDA summary names no predicate by number. 97 later devices descend from it.
- Decided
- Oct 1, 1996
- Review
- 75 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
97 later devices descend from it, 12 citing it directly.
- This deviceK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- Descendant · cites it directly · 30 of its ownK073485 Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2008
- Descendant · cites it directly · 26 of its ownK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- Descendant · cites it directly · 20 of its ownK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- Descendant · cites it directly · 18 of its ownK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
- Descendant · 2 generations on · 17 of its ownK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K073485Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2008 · cites it directly30descendants
- K020927Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact LensBausch & Lomb · 2002 · cites it directly26descendants
- K991134Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999 · cites it directly20descendants
- K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005 · cites it directly18descendants
- K994324Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| +1 | K073485 | Vistakon (Narafilcon) a Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2008 | — |
| +1 | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| +1 | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| +1 | K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision, Inc. | 2005 | — |
| +2 | K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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?
The FDA summary names no predicate by number.
What descends from it? (97)
See all 9712 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073485 | Vistakon (Narafilcon) a Soft Contact Lens | 2008 | 30 |
| K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | 2002 | 26 |
| K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with… | 1999 | 20 |
| K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | 2005 | 18 |
| K100349 | Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker | 2010 | 13 |
| K083288 | Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker | 2009 | 13 |
| K120028 | Aquamax (Etafilcon a) Disposable Soft Contact Lenses | 2012 | 10 |
| K980634 | Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted) | 1998 | 7 |
| K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft… | 2016 | 6 |
| K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker | 2003 | 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?
- Of its descendants, K073485 (Johnson & Johnson Vision Care, Inc., 2008) has gone furthest, with 30 descendants of its own.
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, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less. The ACUVUE MULTIFOCAL 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 of astigmatism…
Read the full statement (152 words)
The ACUVUE Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and presbyopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The ACUVUE MULTIFOCAL 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 of astigmatism or less.
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 of astigmatism or less.
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/K962804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/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/K962804
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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