510(k) · Cleared
ClearedLens Plus Rewetting Drops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Optics, Inc. · LPN Accessories, Soft Lens Products
Cleared on Jul 29, 2005 after a 311-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Jul 29, 2005
- Review
- 311 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK042562 Lens Plus Rewetting DropsAdvanced Medical Optics, Inc. · 2005
- Descendant · cites it directly · 9 of its ownK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- Descendant · 2 generations on · 8 of its ownK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK170483 Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017
- Descendant · 3 generations on · 1 of its ownK201069 VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K093367Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010 · cites it directly9descendants
- K110221Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011 · 2 generations on8descendants
- K151768Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015 · 2 generations on6descendants
- K170483Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated · 2017 · 3 generations on2descendants
- K201069VibrantVue Scleral SalineDry Eye Innovations, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042562 | Lens Plus Rewetting Drops | Advanced Medical Optics, Inc. | 2005 | — |
| +1 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| +2 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| +2 | K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015 | — |
| +3 | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | Bausch & Lomb, Incorporated | 2017 | — |
| +3 | K201069 | VibrantVue Scleral Saline | Dry Eye Innovations, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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 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
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 |
|---|---|---|---|
| * | — | Lens Plus® Rewetting Drops with the single-use vial Named without a submission number |
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 |
|---|---|---|---|
| K093367 | Sterile Saline Solution | 2010 | 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?
- Of its descendants, K093367 (Cachet Pharmaceuticals Pvt., Ltd., 2010) has gone furthest, with 9 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 | — |
What is it indicated for?
Use LENS PLUS ® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use LENS PLUS ® Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042562: Lens Plus Rewetting Drops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042562
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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