510(k) · Cleared
ClearedOxycor (Balafilcon a) Visibility Tinted Contact Lens
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 Aug 8, 1997 after a 38-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Aug 8, 1997
- Review
- 38 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK972454 Oxycor (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 1997
- Descendant · cites it directly · 13 of its ownK050948 Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK122575 Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact…Bausch & Lomb, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK131208 Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb…Bausch & Lomb, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK132715 Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact…Bausch & Lomb, Incorporated · 2013
- Descendant · 3 generations on · 1 of its ownK223397 HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens…Hoya Lamphun, Ltd. · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K050948Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005 · cites it directly13descendants
- K122575Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb…Bausch & Lomb, Inc. · 2012 · cites it directly10descendants
- K131208Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Bausch & Lomb, Inc. · 2013 · 2 generations on9descendants
- K132715Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact LensBausch & Lomb, Incorporated · 2013 · 2 generations on3descendants
- K223397HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina…Hoya Lamphun, Ltd. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972454 | Oxycor (Balafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 1997 | — |
| +1 | K050948 | Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 2005 | — |
| +1 | K122575 | Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch… | Bausch & Lomb, Inc. | 2012 | — |
| +2 | K131208 | Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort… | Bausch & Lomb, Inc. | 2013 | — |
| +2 | K132715 | Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens | Bausch & Lomb, Incorporated | 2013 | — |
| +3 | K223397 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina… | Hoya Lamphun, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 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? (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 |
|---|---|---|---|
| * | — | BAUSCH & LOMB® Premier 90 (balafilcon A) Contact Lens (clear lens) Named without a submission number | |
| * | — | BAUSCH & LOMB Optima™ 38 (polymacon) Visibility Tinted Contact Lens Named without a submission number |
What descends from it? (15)
See all 152 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?
- Of its descendants, K050948 (Bausch & Lomb, Inc., 2005) has gone furthest, with 13 descendants of its own.
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® OxyCor (balafilcon A) Visibility Tinted Contact Lens is indicated
for vision correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic
and/or non-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.
The lens may be disinfected using either a heat or chemical disinfection system. Eye Care
Practitioners may prescribe the lens for traditional or frequent/planned replacement wearing
schedule, with cleaning, disinfection and scheduled replacement of the lens.
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/K972454 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972454: Oxycor (Balafilcon a) Visibility Tinted Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972454
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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