510(k) Report

510(k) · Cleared

Cleared

Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

K161739510(k) TraditionalCleared Dec 19, 2016178-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

Pegavision Corporation · LPL Lenses, Soft Contact, Daily Wear

Cleared on Dec 19, 2016 as substantially equivalent to K120028 (Pegavision Corporation, 2012) and 2 other predicates after a 178-day review. Its family tree reaches back 4 generations to 1996. 6 later devices descend from it.

Decided
Dec 19, 2016
Review
178 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K962804 (1996). 6 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor2004: 1 other ancestor2020: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 1996K051129 · Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 2005K083288 · Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker · Innova Vision, Inc. · 2009K120028 · Aquamax (Etafilcon a) Disposable Soft Contact Lenses · Pegavision Corporation · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K120028 · Aquamax (Etafilcon a) Disposable Soft Contact Lenses · Pegavision Corporation · 2012K083288 · Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker · Innova Vision, Inc. · 2009K051129 · Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Innova Vision, Inc. · 2005K962804 · Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker · Vistakon, Johnson & Johnson Vision Products, Inc. · 19960
  1. Root · 4 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
  2. 3 generations backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
  3. 2 generations backK083288 Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
  4. 1 generation backK120028 Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012
  5. This deviceK161739 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily…Pegavision Corporation · 2016
  6. Descendant · cites it directly · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
  7. Descendant · 2 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021
  8. Descendant · 3 generations on · 1 of its ownK232839 Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric…Yung Sheng Optical Co., Ltd. · 2024
  9. Descendant · 4 generations on · 0 of its ownK253352 Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2026
  10. Descendant · 2 generations on · 0 of its ownK211603 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2022

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2018: 12020: 12021: 12022: 12024: 12026: 1
2018high 1 (2018) · low 0 (2019)2026

Most influential descendants

Showing 5 of 6 · See all
  • K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · cites it directly4descendants
  • K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 2 generations on2descendants
  • K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft…Yung Sheng Optical Co., Ltd. · 2024 · 3 generations on1descendant
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…Pegavision Corporation · 2026 · 4 generations on0descendants
  • K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerVistakon, Johnson & Johnson Vision Products, Inc.1996—
−3K051129Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc.2005—
−2K083288Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc.2009—
−1K120028Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation2012—
0 (this device)K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable…Pegavision Corporation2016—
+1K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation2020—
+2K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2021—
+3K232839Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon)…Yung Sheng Optical Co., Ltd.2024—
+4K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2026—
+2K211603Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202010
202110
202210
202410
202610
FIG. 1 — Lineage of K161739, 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? (3)

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
*K120028Aquamax (Etafilcon a) Disposable Soft Contact Lenses
Summary page 5
…Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN FDA Classification: Class II Predicate Device Name: K120028 Pegavision Corporation, Aquamax (Etafilcon A) disposable soft (hydrophilic) contact lenses…
Pegavision Corporation2012—
*K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker
Summary page 5
…edicate Device Name: K120028 Pegavision Corporation, Aquamax (Etafilcon A) disposable soft (hydrophilic) contact lenses K962804 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) Spherical, Toric, and Multifocal, and…
Vistakon, Johnson & Johnson Vision Products, Inc.1996—
*K991134Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with…
Summary page 5
…UE (Etafilcon A) Spherical, Toric, and Multifocal, and Toric Multifocal soft (hydrophilic) daily wear contact lenses K 991134 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) spherical, bifocal, toric and toric…
Vistakon, Johnson & Johnson Vision Products, Inc.1999—

Also cleared against K120028: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation20204
K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd.20180

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 20 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K200296 (Pegavision Corporation, 2020) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K120028.

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. 2016, 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?

1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses: Spherical and Aspherical Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or…

Read the full statement (492 words)

1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses:

Spherical and Aspherical

Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric

Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal

Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear.

2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses:

Spherical and Aspherical

Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Toric

Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.

Multifocal

Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The lenses are intended 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.

Also cleared against K120028

1 other device cites the same predicate.

  • K140025Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2014

More from Pegavision Corporation

14 FDA decisions under this applicant name. See the company

  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026
  • K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft…Pegavision Corporation · 2026
  • K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft…Pegavision Corporation · 2026
  • K251095Pegavision (Hioxifilcon A) Daily Disposable Soft Contact LensesPegavision Corporation · 2025
  • K243868Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft…Pegavision Corporation · 2025

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/K161739 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161739: Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) 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/K161739

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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