510(k) Report

510(k) · Cleared

Cleared

Vistakon (Narafilcon) a Soft Contact Lens

K073485510(k) TraditionalCleared Mar 3, 200882-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

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

Cleared on Mar 3, 2008 as substantially equivalent to K032340 (Johnson & Johnson Vision Care, Inc., 2003) and 1 other predicate after an 82-day review. Its family tree reaches back 1 generation to 1996. 30 later devices descend from it.

Decided
Mar 3, 2008
Review
82 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K962804 (1996). 2 ancestors in all. 30 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2010: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2012: 1 descendant cleared2018: 8 descendants cleared2020: 5 descendants cleared2019: 2 descendants cleared2023: 3 descendants cleared2026: 2 descendants cleared2025: 3 descendants cleared2024: 2 descendants clearedK962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 9 descendants3 generations forward: 10 descendants4 generations forward: 6 descendants5 generations forward: 1 descendant K962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 19960+5
  1. Root · 1 generation backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
  2. This deviceK073485 Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2008
  3. Descendant · cites it directly · 13 of its ownK100349 Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc. · 2010
  4. Descendant · 2 generations on · 12 of its ownK113168 Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal…Ciba Vision Corporation · 2012
  5. Descendant · cites it directly · 8 of its ownK160344 Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens…Visco Vision, Inc. · 2016
  6. Descendant · cites it directly · 6 of its ownK130331 Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily…Sauflon Pharmaceuticals, Ltd. · 2013 · Recalled
  7. Descendant · 3 generations on · 4 of its ownK182902 Precision1Alcon Laboratories, Inc. · 2018 · Recalled

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12014: 12016: 12018: 82019: 22020: 52023: 32024: 22025: 32026: 2
2010high 8 (2018) · low 0 (2011)2026

Most influential descendants

Showing 5 of 30 · See all
  • K100349Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc. · 2010 · cites it directly13descendants
  • K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies Total…Ciba Vision Corporation · 2012 · 2 generations on12descendants
  • K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B)…Visco Vision, Inc. · 2016 · cites it directly8descendants
  • K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Sauflon Pharmaceuticals, Ltd. · 2013 · cites it directly6descendants
  • K182902Precision1Alcon Laboratories, Inc. · 2018 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerVistakon, Johnson & Johnson Vision Products, Inc.1996—
0 (this device)K073485Vistakon (Narafilcon) a Soft Contact LensJohnson & Johnson Vision Care, Inc.2008—
+1K100349Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.2010—
+2K113168Dailies Total Dalies Total for Astigmatism Dailies Total Multifocal Dailies…Ciba Vision Corporation2012—
+1K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy…Visco Vision, Inc.2016—
+1K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable…Sauflon Pharmaceuticals, Ltd.201317
+3K182902Precision1Alcon Laboratories, Inc.20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201410
201610
201880
201920
202050
202330
202420
202530
202620
FIG. 1 — Lineage of K073485, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K032340Vistakon (Galyfilcon a) Soft Contact Lens
Summary page 1
…Device Classification: Class 11, 21 CFR 886.5925 (b) (1). Predicate Material Device(s) VISTAKON® (galyfilcon A) Contact Lens - K032340 (FDA Group I; low water, nonionic polymer) Indication, Wear Schedule…
Johnson & Johnson Vision Care, Inc.20031
*K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker
Summary page 1
…0 (FDA Group I; low water, nonionic polymer) Indication, Wear Schedule VISTAKON® (etafilcon) Contact Lenses - K962804 (Daily wear, single use) Continuedo…
Vistakon, Johnson & Johnson Vision Products, Inc.1996—

Also cleared against K032340: 1 other device →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K100349Vistakon (Narafilcon B) Contact Lens Visibility Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.201013
K160344Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B)…Visco Vision, Inc.20168
K130331Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…Sauflon Pharmaceuticals, Ltd.20136
K133472Sauflon Clariti 1 Day with Tint (Toric/Multifocal)Souflon Pharmaceuticals, Ltd.20140

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K100349 (Johnson & Johnson Vision Care, Inc., 2010) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K032340.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
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

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

The VISTAKON® (narafilcon A) 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 1.000 or less of astigmatism. The VISTAKON® (narafilcon A) 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 (223 words)

The VISTAKON® (narafilcon A) 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 1.000 or less of astigmatism.

The VISTAKON® (narafilcon A) 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 0.75D of astigmatism or less.

The VISTAKON® (narafilcon A)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 A) 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 10.00D of astigmatism or less.

VISTAKON® (narafilcon A) 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 disinfecting is required.

Indications for use as stated in the FDA summary.

Also cleared against K032340

1 other device cites the same predicate.

  • K130342Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerSauflon Pharmaceuticals, Ltd. · 2013

More from Johnson & Johnson Vision Care, Inc.

14 FDA decisions under this applicant name. See the company

  • K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)Johnson & Johnson Vision Care, Inc. · 20211 recall
  • K200243ACUVUE (senofilcon A) Soft Contact Lens MultifocalJohnson & Johnson Vision Care, Inc. · 2020
  • K180299ACUVUE OASYS (senofilcon A) with Photochromic AdditiveJohnson & Johnson Vision Care, Inc. · 2018
  • K160212ACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc. · 20161 recall
  • K141670Acuvue (Etafilcon a) Soft Contact Lens for PresbyopiaJohnson & Johnson Vision Care, Inc. · 2014

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K073485 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073485: Vistakon (Narafilcon) a Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073485

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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