510(k) Report

510(k) · Cleared

Cleared

Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses

K140025510(k) TraditionalCleared Oct 15, 2014282-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 Oct 15, 2014 as substantially equivalent to K120028 (Pegavision Corporation, 2012) and 2 other predicates after a 282-day review. Its family tree reaches back 4 generations to 1996. 2 later devices descend from it.

Decided
Oct 15, 2014
Review
282 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. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2004: 1 other ancestor2015: 1 descendant cleared2017: 1 descendant clearedReference device: K991134 · Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with UV Blocker, for Daily Wear · Vistakon, Johnson & Johnson Vision Products, Inc. · 1999K962804 · 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: 1 descendant2 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 deviceK140025 Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic)…Pegavision Corporation · 2014
  6. Descendant · cites it directly · 1 of its ownK150385 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2015
  7. Descendant · 2 generations on · 0 of its ownK173086 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2017

Most influential descendants

Showing 2 of 2 · See all
  • K150385NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc. · 2015 · cites it directly1descendant
  • K173086NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc. · 2017 · 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)K140025Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation2014—
+1K150385NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc.2015—
+2K173086NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
FIG. 1 — Lineage of K140025, 1996–2017Source: 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 7
…nses, and NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses with the same established safety profile and effectiveness of the predicate devices K120028 Aquamax (Etafilcon A) Disposable and Bi-weekly Soft (Hydrophilic) Contact Lenses for spherical and aspheric lenses for myopia and…
Pegavision Corporation2012—
*K013445Osprey Spherical and Toric Multifocal Soft Contact Lenses
Summary page 6
…K120228 Pegavision Corporation, Aquamax (Etafilcon A) disposable soft (hydrophilic) contact lenses K013445 Florida Optical Engineering, OSPREY spherical and Multifocal Toric soft daily wear contact lenses…
Florida Optical Engineering, Inc.2001—
*K962804Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker
Summary page 7
…Page 1 of 6 Pegavision Corporation K140025 K962804 Vistakon, Johnson & Johnson Vision Products, ACUVUE (Etafilcon A) Spherical, Toric, and Multifocal,…
Vistakon, Johnson & Johnson Vision Products, Inc.1996—
†K991134Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with…Vistakon, Johnson & Johnson Vision Products, Inc.1999—

Also cleared against K120028: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150385NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc.20151

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 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K150385 (Visioneering Technologies, Inc., 2015) has gone furthest, with 1 descendant 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. 2014, 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 Aspheric 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 (986 words)

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

Spherical and Aspheric

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.

Multifocal Toric

Aquamax (Etafilcon A) Multifocal Toric 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 10.00 diopters or less.

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 for Frequent Replacement (Replacement Recommended Every 2 Weeks):

Spherical and Aspheric

Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement 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 for Frequent Replacement 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 for Frequent Replacement 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.

Multifocal Toric

Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement 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 10.00 diopters or less.

Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement 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. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended 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.

3. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

Spherical and Aspheric

NaturalVue (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

NaturalVue (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

NaturalVue (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.

Multifocal Toric

NaturalVue (Etafilcon A) Multifocal Toric 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 10.00 diopters or less.

NaturalVue (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.

Indications for use as stated in the FDA summary.

Also cleared against K120028

1 other device cites the same predicate.

  • K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation · 2016

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

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The LPL category page

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https://510kreport.com/device/K140025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140025: Aquamax (Etafilcon a) BI-Weekly 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/K140025

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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