PMA · Approved
ApprovedBausch & Lomb (R) Renu (R) Multi-Purpose Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · LPN Accessories, Soft Lens Products
Approved on Jul 3, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 232-day review. 3 later devices descend from it.
- Decided
- Jul 3, 1997
- Review
- 232 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceP860023/
S012 Bausch & Lomb (R) Renu (R) Multi-Purpose SolutionBausch & Lomb, Inc. · 1997 - Descendant · cites it directly · 0 of its ownK983973 Opti-One Multi-Purpose SolutionAlcon Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK980775 Complete Brand Multi-Purpose SolutionAllergan, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK981574 Opti-Free Express Multi-Purpose SolutionAlcon · 1998
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P860023/ | Bausch & Lomb (R) Renu (R) Multi-Purpose Solution | Bausch & Lomb, Inc. | 1997 | — |
| +1 | K983973 | Opti-One Multi-Purpose Solution | Alcon Laboratories | 1998 | — |
| +1 | K980775 | Complete Brand Multi-Purpose Solution | Allergan, Inc. | 1998 | — |
| +1 | K981574 | Opti-Free Express Multi-Purpose Solution | Alcon | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPN? 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 LPN device
- #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (3)
3 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, K983973 (Alcon Laboratories, 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 2025
MAUDE reports naming product code LPN, 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 | 4 | 175 | 2 | 1,151 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 1 | — | 2 | 121 |
| 2010 | 2 | — | 2 | 241 |
| 2011 | 3 | 222 | 1 | 273 |
| 2012 | 2 | — | 0 | 268 |
| 2013 | 2 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 105 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 3 | 59 | 1 | 498 |
| 2017 | 1 | — | 0 | 2,666 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 2 | — | 0 | 60 |
| 2020 | 3 | 167 | 1 | 82 |
| 2021 | 2 | — | 0 | 51 |
| 2022 | 2 | — | 0 | 62 |
| 2023 | 0 | — | 0 | 84 |
| 2024 | 0 | — | 0 | 76 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/P860023/S012 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860023/S012: Bausch & Lomb (R) Renu (R) Multi-Purpose Solution.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860023/S012
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026