PMA · Approved

Approved

Bausch & Lomb (R) Renu (R) Multi-Purpose Solution

P860023/S006PMAApproved Jan 24, 19941,033-day reviewClass II21 CFR 886.5928

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bausch & Lomb, Inc. · LPN Accessories, Soft Lens Products

Approved on Jan 24, 1994 through premarket approval, which rests on the device’s own clinical evidence after a 1,033-day review. 1 later device descends from it.

Decided: Jan 24, 1994
Review: 1,033 days
Class: Class II
Product code: LPN
Recalls: None

1 later device descends from it, 1 citing it directly.

This deviceP860023/S006 Bausch & Lomb (R) Renu (R) Multi-Purpose SolutionBausch & Lomb, Inc. · 1994
Descendant · cites it directly · 0 of its ownK991965 Purilens System for Cleaning and Disinfecting Contact LensesPurilens, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K991965Purilens System for Cleaning and Disinfecting Contact LensesPurilens, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	P860023/S006	Bausch & Lomb (R) Renu (R) Multi-Purpose Solution	Bausch & Lomb, Inc.	1994	—
+1	K991965	Purilens System for Cleaning and Disinfecting Contact Lenses	Purilens, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of P860023/S006, 1994–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K991965	Purilens System for Cleaning and Disinfecting Contact Lenses	Purilens, Inc.	1999	0

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, K991965 (Purilens, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LPN devices

LPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPN

2in 2022

2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007high 222 (2011) · low 59 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPN

1in 2020

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPN

40in 2025

2007high 2,666 (2017) · low 40 (2025)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/S006 · printed Nov 6, 2026

Cite this page

510(k) Report. “P860023/S006: 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/S006

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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