510(k) · Cleared
ClearedACUVUE (senofilcon A) Soft Contact Lens Multifocal
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 Mar 17, 2020 as substantially equivalent to K042275 (Vistakon, 2004) after a 46-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Mar 17, 2020
- Review
- 46 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042275 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK042275 Vistakon (Senofilcon a) Soft Contact LensVistakon · 2004 · Recalled
- This deviceK200243 ACUVUE (senofilcon A) Soft Contact Lens MultifocalJohnson & Johnson Vision Care, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042275 | Vistakon (Senofilcon a) Soft Contact Lens | Vistakon | 2004 | 3 |
| 0 (this device) | K200243 | ACUVUE (senofilcon A) Soft Contact Lens Multifocal | Johnson & Johnson Vision Care, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K042275 | Vistakon (Senofilcon a) Soft Contact LensSummary page 4…lassification: Class II, 21 CFR 886.5925 (b) (1) Product Code: LPL, MVN Predicate Device: • VISTAKON® (senofilcon A) Contact Lens, cleared via K042275 Reference Device: Optical Design • ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Clear and Tinted (… | 2004 |
| † | K141670 | Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia | 2014 |
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?
- Its one ancestor has a recall.
- 3 other devices also cite its predicate K042275.
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. 2020, 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 ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00 of ADD power and have 0.75D or less of astigmatism. The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia…
Read the full statement (197 words)
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00 of ADD power and have 0.75D or less of astigmatism.
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.
Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional.
When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2 weeks (14 days).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200243: ACUVUE (senofilcon A) Soft Contact Lens Multifocal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200243
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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