510(k) · Cleared
ClearedBausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
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 Mar 8, 2023 as substantially equivalent to K200528 (Bausch + Lomb, Incorporated, 2020) and 1 other predicate after a 370-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Mar 8, 2023
- Review
- 370 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K974780 (1998). 15 ancestors in all, the oldest K960926 (1996). No later device cites it as a predicate yet.
- Root · 7 generations backK974780 Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted…Bausch & Lomb, Inc. · 1998
- 6 generations backK983894 Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1998
- 5 generations backK994125 Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact LensesBausch & Lomb, Inc. · 2000
- 4 generations backK061157 Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted…Bausch & Lomb · 2006
- 3 generations backK113703 Bausch + Lomb Nesofilcon a Contact LensBausch & Lomb, Incorporated · 2012 · Recalled
- 2 generations backK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
- 1 generation backK210975 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for…Bausch & Lomb, Incorporated · 2021
- This deviceK220613 Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch…Bausch & Lomb, Incorporated · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K974780 | Soflens (TM) One Day Disposable (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −6 | K983894 | Bausch & Lomb Phoenix (Hilafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1998 | — |
| −5 | K994125 | Bausch & Lomb 2-Week (Hilafilcon B) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. | 2000 | — |
| −4 | K061157 | Soflens One Day Plus Disposable (Hilafilcon B) Visibility Tinted Contact Lens | Bausch & Lomb | 2006 | — |
| −3 | K113703 | Bausch + Lomb Nesofilcon a Contact Lens | Bausch & Lomb, Incorporated | 2012 | 1 |
| −2 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
| −1 | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | Bausch & Lomb, Incorporated | 2021 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft…Summary page 4…ate Devices: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens and Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism cleared under K200528 and Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens cleared under K210975. Device Description:… | 2020 |
| * | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaSummary page 4…omb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism cleared under K200528 and Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens cleared under K210975. Device Description: Page 1 of 5 =… | 2021 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K200528.
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. 2023, 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?
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) 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 maybe prescribed in spherical powers ranging from +20.00D to -20.00D. Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens…
Read the full statement (186 words)
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) 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 maybe prescribed in spherical powers ranging from +20.00D to -20.00D.
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) 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.
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is 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, exhibiting 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 with add powers ranging from +0.75D to +5.00D.
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/K220613 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220613: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220613
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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