510(k) · Cleared
ClearedBiotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Incorporated · LPL Lenses, Soft Contact, Daily Wear
Cleared on Feb 11, 2016 as substantially equivalent to K113703 (Bausch & Lomb, Incorporated, 2012) and 2 other predicates after a 213-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Feb 11, 2016
- Review
- 213 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K974780 (1998). 16 ancestors in all, the oldest K960926 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK974780 Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted…Bausch & Lomb, Inc. · 1998
- 5 generations backK983894 Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1998
- 4 generations backK994125 Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesBausch & Lomb, Inc. · 2000
- 3 generations backK061157 Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted…Bausch & Lomb · 2006
- 2 generations backK113703 Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · Recalled
- 1 generation backK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
- This deviceK151918 Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with…Bausch & Lomb, Incorporated · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −5 | K983894 | Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −4 | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. | 2000 | — |
| −3 | K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb | 2006 | — |
| −2 | K113703 | Bausch + Lomb Nesofilcon a Contact Lens | Bausch & Lomb, Incorporated | 2012 | 1 |
| −1 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
| 0 (this device) | K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist… | Bausch & Lomb, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113703 | Bausch + Lomb Nesofilcon a Contact LensSummary page 4…on Class II (21 CFR 886.5925 (b) (1)) Predicate Devices Biotrue ONEday (nesofilcon A) Soft (Hydrophilic) Contact Lenses cleared under K113703, Biotrue ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lenses cle… | 2012 |
| * | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensSummary page 4…under K113703, Biotrue ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lenses cleared under K132715, and Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lense… | 2013 |
| * | K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact…Summary page 4…es cleared under K132715, and Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lenses cleared under K143632. Device Description: The Biotrue ONEday Contact Lens with NaturMoist is a soft hydrophilic contact lens. The lenses are made from… | 2015 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 3 other devices also cite its predicate K113703.
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. 2016, 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: The Bausch + Lomb Lomb Biotrue® ONEday (nesofilcon A) Contact Lens with NaturMoist is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.00D to -20.00D. Multifocal…
Read the full statement (227 words)
Spherical:
The Bausch + Lomb Lomb Biotrue® ONEday (nesofilcon A) Contact Lens with NaturMoist is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism up to 2.00 diopters or less, that does not interfere with visual acuity. The lens is to be prescribed in spherical powers ranging from +20.00D to -20.00D.
Multifocal:
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.
Toric:
The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens with NaturMoist is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151918: Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151918
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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