510(k) · Cleared
Recalled · Class II · 2019Vistakon (Senofilcon a) Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vistakon · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 28, 2004 after a 66-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 28, 2004
- Review
- 66 days
- Class
- Class II
- Product code
- LPL
- Recalls
- 3
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK042275 Vistakon (Senofilcon a) Soft Contact LensVistakon · 2004
- Descendant · cites it directly · 2 of its ownK240477 Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)…St. shine Optical Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK250364 Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft…St. shine Optical Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK254269 Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft…St. shine Optical Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK210930 ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)Johnson & Johnson Vision Care, Inc. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK200243 ACUVUE (senofilcon A) Soft Contact Lens MultifocalJohnson & Johnson Vision Care, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K240477Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview…St. shine Optical Co., Ltd. · 2024 · cites it directly2descendants
- K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd. · 2025 · 2 generations on1descendant
- K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd. · 2026 · 3 generations on0descendants
- K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)Johnson & Johnson Vision Care, Inc. · 2021 · cites it directly0descendants
- K200243ACUVUE (senofilcon A) Soft Contact Lens MultifocalJohnson & Johnson Vision Care, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042275 | Vistakon (Senofilcon a) Soft Contact Lens | Vistakon | 2004 | — |
| +1 | K240477 | Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact… | St. shine Optical Co., Ltd. | 2024 | — |
| +2 | K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)… | St. shine Optical Co., Ltd. | 2025 | — |
| +3 | K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic)… | St. shine Optical Co., Ltd. | 2026 | — |
| +1 | K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | Johnson & Johnson Vision Care, Inc. | 2021 | 1 |
| +1 | K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Johnson & Johnson Vision Care, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | — | Focus® NIGHT AND DAY™ (lotrafilcon A) Contact Lens Named without a submission number |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240477 | Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview… | 2024 | 2 |
| K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | 2021 | 0 |
| K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | 2020 | 0 |
| K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2019 | Class II | Z-1131-2019 | Equipment maintenance | One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited number of individual contact lens packages to have an incomplete packaging seal. |
| Dec 18, 2017 | Class II | Z-1744-2020 | Packaging | Package integrity failure observed during routine shift package integrity testing at an external re-packager. |
| Oct 19, 2017 | Class II | Z-1209-2018 | Packaging process control | Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K240477 (St. shine Optical Co., Ltd., 2024) has gone furthest, with 2 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 VISTAKON® (senofilcon A)Contact Lens is indicated for daily wear for the 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® (senofilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism…
Read the full statement (211 words)
The VISTAKON® (senofilcon A)Contact Lens is indicated for daily wear for the 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® (senofilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON® (senofilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have I0.00 Dof astigmatism or less.
The VISTAKON® (senofilcon A) Multifocal-Toric Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
VISTAKON® (senofilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042275: Vistakon (Senofilcon a) Soft Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042275
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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