510(k) · Cleared
ClearedBausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb Purevision Toric (Balafilcon a) VI
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 Dec 20, 2012 as substantially equivalent to K972454 (Bausch & Lomb, Inc., 1997) after a 119-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it.
- Decided
- Dec 20, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972454 (1997). 10 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972454 Oxycor (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1997
- This deviceK122575 Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact…Bausch & Lomb, Inc. · 2012
- Descendant · cites it directly · 9 of its ownK131208 Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb…Bausch & Lomb, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK223397 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…Hoya Lamphun, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK223585 Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic)…Yung Sheng Optical Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK143632 Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft…Bausch & Lomb, Incorporated · 2015
- Descendant · 3 generations on · 0 of its ownK261812 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…HOYA Lamphun, Ltd. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K131208Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Bausch & Lomb, Inc. · 2013 · cites it directly9descendants
- K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd. · 2024 · 2 generations on1descendant
- K223585Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…Yung Sheng Optical Co., Ltd. · 2023 · 2 generations on1descendant
- K143632Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact…Bausch & Lomb, Incorporated · 2015 · 2 generations on1descendant
- K261812HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…HOYA Lamphun, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972454 | Oxycor (Balafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1997 | — |
| 0 (this device) | K122575 | Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch… | Bausch & Lomb, Inc. | 2012 | — |
| +1 | K131208 | Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort… | Bausch & Lomb, Inc. | 2013 | — |
| +2 | K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina… | Hoya Lamphun, Ltd. | 2024 | — |
| +2 | K223585 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens… | Yung Sheng Optical Co., Ltd. | 2023 | — |
| +2 | K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic)… | Bausch & Lomb, Incorporated | 2015 | — |
| +3 | K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina… | HOYA Lamphun, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K972454 | Oxycor (Balafilcon a) Visibility Tinted Contact LensSummary page 1…demonstrate substantial equivalence of the lens material, replacement schedules, and indications for use. OxyCor was cleared in 510(k) Premarket Notification K972454 on August 8, 1997. 4.0 Device Description The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens an… | 1997 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131208 | Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon… | 2013 | 9 |
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?
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. 2012, 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?
The BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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 may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.000 to…
Read the full statement (250 words)
The BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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 may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.000 to -20.00D for daily wear.
The BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens 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 may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.000 to -20.000 for daily wear.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact 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.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122575: Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb Purevision Toric (Balafilcon a) VI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122575
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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