510(k) · Cleared
ClearedBausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
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 Jun 2, 2020 as substantially equivalent to K113703 (Bausch & Lomb, Incorporated, 2012) after a 92-day review. Its family tree reaches back 5 generations to 1998. 2 later devices descend from it.
- Decided
- Jun 2, 2020
- Review
- 92 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K974780 (1998). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK974780 Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted…Bausch & Lomb, Inc. · 1998
- 4 generations backK983894 Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1998
- 3 generations backK994125 Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesBausch & Lomb, Inc. · 2000
- 2 generations backK061157 Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted…Bausch & Lomb · 2006
- 1 generation backK113703 Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · Recalled
- This deviceK200528 Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb…Bausch + Lomb, Incorporated · 2020
- Descendant · cites it directly · 1 of its ownK210975 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for…Bausch & Lomb, Incorporated · 2021
- Descendant · cites it directly · 0 of its ownK220613 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch…Bausch & Lomb, Incorporated · 2023
Most influential descendants
Showing 2 of 2 · See all- K210975Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaBausch & Lomb, Incorporated · 2021 · cites it directly1descendant
- K220613Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon…Bausch & Lomb, Incorporated · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −4 | K983894 | Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −3 | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. | 2000 | — |
| −2 | K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb | 2006 | — |
| −1 | K113703 | Bausch + Lomb Nesofilcon a Contact Lens | Bausch & Lomb, Incorporated | 2012 | 1 |
| 0 (this device) | K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A)… | Bausch + Lomb, Incorporated | 2020 | — |
| +1 | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb, Incorporated | 2021 | — |
| +1 | K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb… | Bausch & Lomb, Incorporated | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K113703 | Bausch + Lomb Nesofilcon a Contact LensSummary page 4…ch + Lomb kalifilcon A Contact Lens is substantially equivalent to the following predicate device: Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens cleared under K113703. Device Description: The Bausch + Lomb kalifilcon A material is made from a hydrophilic siloxane copolymer of 2-hydroxyethyl me… | 2012 |
What descends from it? (2)
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 22 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K210975 (Bausch & Lomb, Incorporated, 2021) has gone furthest, with 1 descendant of its own.
- 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. 2020, 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?
Kalifilcon A Contact Lens Bausch + Lomb kalifilcon A Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D. Kalifilcon A Contact Lens for Astigmatism Bausch + Lomb…
Read the full statement (123 words)
Kalifilcon A Contact Lens
Bausch + Lomb kalifilcon A Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
Kalifilcon A Contact Lens for Astigmatism
Bausch + Lomb kalifilcon A Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.
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/K200528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200528: Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200528
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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