510(k) · Cleared
ClearedNaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visioneering Technologies, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 7, 2017 as substantially equivalent to K150385 (Visioneering Technologies, Inc., 2015) after a 39-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Nov 7, 2017
- Review
- 39 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K962804 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 5 generations backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
- 4 generations backK083288 Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
- 3 generations backK120028 Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012
- 2 generations backK140025 Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic)…Pegavision Corporation · 2014
- 1 generation backK150385 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2015
- This deviceK173086 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −5 | K051129 | Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear | Innova Vision, Inc. | 2005 | — |
| −4 | K083288 | Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker | Innova Vision, Inc. | 2009 | — |
| −3 | K120028 | Aquamax (Etafilcon a) Disposable Soft Contact Lenses | Pegavision Corporation | 2012 | — |
| −2 | K140025 | Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2014 | — |
| −1 | K150385 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | 2015 | — |
| 0 (this device) | K173086 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K150385 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesSummary page 4…Class II Lens, Contact, (Disposable), per 21 CFR 886.5925, Product Code: MVN PREDICATE K150385 Visioneering Technologies, Inc., NaturalVue DEVICE (etafilcon A) Daily Disposable Soft (Hydrophilic) Contac… | 2015 |
| † | K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft… | 2016 |
| † | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | 1996 |
| † | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with… | 1999 |
| † | K120028 | Aquamax (Etafilcon a) Disposable Soft Contact Lenses | 2012 |
| † | K140025 | Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses | 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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
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. 2017, 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?
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…
Read the full statement (273 words)
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/or 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) Toric Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or 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.
The lenses are intended for single-use disposable wear.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173086: NaturalVue (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/K173086
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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