510(k) · Cleared
ClearedAquamax (Etafilcon a) Disposable Soft Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pegavision Corporation · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 17, 2012 as substantially equivalent to K962804 (Vistakon, Johnson & Johnson Vision Products, Inc., 1996) and 1 other predicate after a 104-day review. Its family tree reaches back 3 generations to 1996. 10 later devices descend from it.
- Decided
- Apr 17, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K962804 (1996). 4 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 2 generations backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
- 1 generation backK083288 Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
- This deviceK120028 Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012
- Descendant · cites it directly · 6 of its ownK161739 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily…Pegavision Corporation · 2016
- Descendant · 2 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
- Descendant · 3 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021
- Descendant · cites it directly · 2 of its ownK140025 Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic)…Pegavision Corporation · 2014
- Descendant · 4 generations on · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft…Pegavision Corporation · 2016 · cites it directly6descendants
- K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 2 generations on4descendants
- K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 3 generations on2descendants
- K140025Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2014 · cites it directly2descendants
- K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −2 | K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision, Inc. | 2005 | — |
| −1 | K083288 | Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker | Innova Vision, Inc. | 2009 | — |
| 0 (this device) | K120028 | Aquamax (Etafilcon a) Disposable Soft Contact Lenses | Pegavision Corporation | 2012 | — |
| +1 | K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable… | Pegavision Corporation | 2016 | — |
| +2 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact… | Pegavision Corporation | 2020 | — |
| +3 | K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses… | Pegavision Corporation | 2021 | — |
| +1 | K140025 | Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2014 | — |
| +4 | K232839 | Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)… | Yung Sheng Optical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerSummary page 3…y Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses ACUVUE Contact Lens clear -and visibility tint with UIV blocker (K962804); and Discon Plus Contact Lens visibility tint with UV Blocker. The evidence of substantial equivalence to the predicate lenses i… | 1996 |
| * | K083288 | Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerSummary page 3…nd visibility tint with UN' blocker, K 962808 Submitted by Vistakon USA 0 Discon Plus (Etafilcon A) Contact Lens, visibility tint with UIV blocker, K083288, submitted by Innova Vision, Taiwan. Clinical studies for Aquamix Bi-Weckly Disposable Soft (Hydrophilic) Contact Lenses… | 2009 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K161739 (Pegavision Corporation, 2016) has gone furthest, with 6 descendants of its own.
- 11 other devices also cite its predicate K962804.
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. 2012, 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?
1. PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydroplil) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging…
Read the full statement (205 words)
1. PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydroplil) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.OOD) to -12.OOD. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear.
2. PEGAVISION Aquarm (Etafflcon A) Bi-weeldy Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.OOD to -12.OOD. Eye Care Practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120028: Aquamax (Etafilcon a) Disposable Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120028
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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