510(k) · Cleared
ClearedBausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 3, 2000 as substantially equivalent to K974780 (Bausch & Lomb, Inc., 1998) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1998. 10 later devices descend from it.
- Decided
- Mar 3, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974780 (1998). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974780 Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted…Bausch & Lomb, Inc. · 1998
- 1 generation backK983894 Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1998
- This deviceK994125 Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesBausch & Lomb, Inc. · 2000
- Descendant · cites it directly · 9 of its ownK061157 Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted…Bausch & Lomb · 2006
- Descendant · 2 generations on · 6 of its ownK113703 Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
- Descendant · 3 generations on · 2 of its ownK200528 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb…Bausch + Lomb, Incorporated · 2020
- Descendant · 4 generations on · 1 of its ownK210975 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for…Bausch & Lomb, Incorporated · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K061157Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact LensBausch & Lomb · 2006 · cites it directly9descendants
- K113703Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · 2 generations on6descendants
- K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated · 2013 · 3 generations on3descendants
- K200528Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft…Bausch + Lomb, Incorporated · 2020 · 3 generations on2descendants
- K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −1 | K983894 | Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| 0 (this device) | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. | 2000 | — |
| +1 | 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 |
| +3 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
| +3 | K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A)… | Bausch + Lomb, Incorporated | 2020 | — |
| +4 | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb, Incorporated | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact LensSummary page 1…Name: BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens Predicate Devices: SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens (K974780) Phoenix (hilafilcon A) Visibility Tinted Contact Lens (K983894) 510(k) PREMARKET NOTIFICATION BAUSCH & LOMB® 2-… | 1998 |
| * | K983894 | Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensSummary page 1…tact Lens Predicate Devices: SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens (K974780) Phoenix (hilafilcon A) Visibility Tinted Contact Lens (K983894) 510(k) PREMARKET NOTIFICATION BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens 4. DESCRIPTI… | 1998 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061157 (Bausch & Lomb, 2006) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K974780.
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.
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?
The BAUSCH & LOMB® 2 -Week (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D. Replacement schedules may vary from patient to patient and should be decided by…
Read the full statement (117 words)
The BAUSCH & LOMB® 2 -Week (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
Replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994125: Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted 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/K994125
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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