510(k) · Cleared
ClearedVistakon (Lenefilcon 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 K991163 (Vistakon, Johnson & Johnson Vision Products, Inc., 1999) after a 63-day review. Its family tree reaches back 2 generations to 1999.
- 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 K983912 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK983912 Vistakon (Lenefilcon a)Contact Lens Clear and Visibility Tint with…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- 1 generation backK991163 Vistakon (Lenefilcon a) Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- This deviceK994318 Vistakon (Lenefilcon a)Soft (Hydrophilic)Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983912 | Vistakon (Lenefilcon a)Contact Lens Clear and Visibility Tint with UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| −1 | K991163 | Vistakon (Lenefilcon a) Soft (Hydrophilic) Contact Lenses, Clear and… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| 0 (this device) | K994318 | Vistakon (Lenefilcon a)Soft (Hydrophilic)Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
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 |
|---|---|---|---|
| * | K991163 | Vistakon (Lenefilcon a) Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint…Summary page 1…e The predicate device is VISTAKON (lenefilcon A) soft (hydrophilic) contact devices lenses, clear and visibility Tinteded, with UV blocker, for daily wear covered under K991163. Description of The device description does not change from that cleared under K991163. device Continued on next page === Pag… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 1 year and passes through 1 company; a new generation was cleared every 9 months on median.
- None of the 2 ancestors has a recall.
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 VISTAKON 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 VISTAKON 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 VISTAKON 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 VISTAKON 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 VISTAKON 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 VISTAKON 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.
VISTAKON 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/K994318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994318: Vistakon (Lenefilcon 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/K994318
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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