510(k) · Cleared

Cleared

NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses

K150385510(k) TraditionalCleared Apr 30, 201571-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

Visioneering Technologies, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Apr 30, 2015 as substantially equivalent to K140025 (Pegavision Corporation, 2014) after a 71-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.

Decided: Apr 30, 2015
Review: 71 days
Class: Class II
Product code: LPL
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K962804 (1996). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
4 generations backK051129 Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearInnova Vision, Inc. · 2005
3 generations backK083288 Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV BlockerInnova Vision, Inc. · 2009
2 generations backK120028 Aquamax (Etafilcon a) Disposable Soft Contact LensesPegavision Corporation · 2012
1 generation backK140025 Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic)…Pegavision Corporation · 2014
This deviceK150385 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2015
Descendant · cites it directly · 0 of its ownK173086 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Visioneering Technologies, Inc. · 2017

Most influential descendants

Showing 1 of 1 · See all

K173086NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesVisioneering Technologies, Inc. · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K962804	Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker	Vistakon, Johnson & Johnson Vision Products, Inc.	1996	—
−4	K051129	Discon (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear	Innova Vision, Inc.	2005	—
−3	K083288	Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker	Innova Vision, Inc.	2009	—
−2	K120028	Aquamax (Etafilcon a) Disposable Soft Contact Lenses	Pegavision Corporation	2012	—
−1	K140025	Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses	Pegavision Corporation	2014	—
0 (this device)	K150385	NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses	Visioneering Technologies, Inc.	2015	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K150385, 1996–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K140025	Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses Summary page 5 …Class II Lens, Contact, (Disposable), per 21 CFR 886.5925, Product Code: MVN PREDICATE K140025 Pegavision Corporation, NaturalVue (etafilcon A) DEVICE Daily Disposable Soft (Hydrophilic) Contact Lenses…	Pegavision Corporation	2014	—
†	K962804	Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker	Vistakon, Johnson & Johnson Vision Products, Inc.	1996	—
†	K991134	Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility Tint, with…	Vistakon, Johnson & Johnson Vision Products, Inc.	1999	—
†	K120028	Aquamax (Etafilcon a) Disposable Soft Contact Lenses	Pegavision Corporation	2012	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K173086	NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses	Visioneering Technologies, Inc.	2017	0

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 19 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
None of the 7 ancestors has a recall.
Of its descendants, K173086 (Visioneering Technologies, Inc., 2017) has gone furthest, with 0 descendants of its own.

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. 2015, this device’s year, is highlighted.

FDA decisions per year · LPL

12in 2025

2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

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

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

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 (298 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 Spherical

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 nonaphakic 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 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.

https://510kreport.com/device/K150385 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150385: 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/K150385

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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