510(k) · Cleared
ClearedVistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Vision Care, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on May 21, 2010 as substantially equivalent to K073485 (Johnson & Johnson Vision Care, Inc., 2008) and 1 other predicate after a 98-day review. Its family tree reaches back 2 generations to 1996. 13 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962804 (1996). 3 ancestors in all. 13 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 backK073485 Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2008
- This deviceK100349 Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc. · 2010
- Descendant · cites it directly · 12 of its ownK113168 Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal…Ciba Vision Corporation · 2012
- Descendant · 2 generations on · 4 of its ownK182902 Precision1Alcon Laboratories, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK180398 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives…Alcon Laboratories, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK230785 Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK233856 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for…Alcon Laboratories, Inc. · 2023 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total…Ciba Vision Corporation · 2012 · cites it directly12descendants
- K182902Precision1Alcon Laboratories, Inc. · 2018 · 2 generations on4descendants
- K180398Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…Alcon Laboratories, Inc. · 2018 · 2 generations on4descendants
- K230785Precision1, Precision1 for AstigmatismAlcon Laboratories, Inc. · 2023 · 3 generations on3descendants
- K233856Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…Alcon Laboratories, Inc. · 2023 · 3 generations on2descendants
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 | K073485 | Vistakon (Narafilcon) a Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2008 | — |
| 0 (this device) | K100349 | Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV Blocker | Johnson & Johnson Vision Care, Inc. | 2010 | — |
| +1 | K113168 | Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies… | Ciba Vision Corporation | 2012 | — |
| +2 | K182902 | Precision1 | Alcon Laboratories, Inc. | 2018 | 1 |
| +2 | K180398 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES… | Alcon Laboratories, Inc. | 2018 | — |
| +3 | K230785 | Precision1, Precision1 for Astigmatism | Alcon Laboratories, Inc. | 2023 | — |
| +3 | K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism… | Alcon Laboratories, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 3 | 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? (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 | Decided |
|---|---|---|---|
| * | K073485 | Vistakon (Narafilcon) a Soft Contact LensSummary page 1…ear Device Classification: Class 111,21 CER 886.5925 (b) (1). Predicate Material Device(s) VISTAKONO (narafilcon A) Contact Lens - K073485 (FDA Group I; low water, nonionic polymer) Indication, Wear Schedule VIS… | 2008 |
| * | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerSummary page 1…85 (FDA Group I; low water, nonionic polymer) Indication, Wear Schedule VISTAKON® (etafilcon A) Contact Lenses - K962804 (Daily wear, single use) Continued o… | 1996 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113168 | Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total… | 2012 | 12 |
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 14 years and passes through 2 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K113168 (Ciba Vision Corporation, 2012) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K073485.
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. 2010, this device’s year, is highlighted.
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®(narafilcon B) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The VISTAKON® (narafilcon B) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or…
Read the full statement (237 words)
The VISTAKON®(narafilcon B) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (narafilcon B) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 4.00D of ADD power or less and 0.75D of astigmatism or less.
The VISTAKON® (narafilcon B) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon B) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 4.00D of ADD power or less and 10.00D of astigmatism or less.
VISTAKON® (narafilcon B) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfection is required.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100349: Vistakon (Narafilcon B) Contact Lens 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/K100349
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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