510(k) · Cleared
ClearedAosept Clear Care Cleaning and Disinfecting Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Nov 19, 2002 after a 98-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Nov 19, 2002
- Review
- 98 days
- Class
- Class II
- Product code
- LYL
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 6 citing it directly.
- This deviceK022687 Aosept Clear Care Cleaning and Disinfecting SolutionCiba Vision Corporation · 2002
- Descendant · cites it directly · 3 of its ownK142284 Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · Recalled
- Descendant · cites it directly · 2 of its ownK162597 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK191872 Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK173538 Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with…Alcon Laboratories, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK112909 OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionBausch & Lomb, Inc. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K142284Clear Care Plus Cleaning & Disinfectiong Solution with HydraglydeAlcon Laboratories, Inc. · 2015 · cites it directly3descendants
- K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2016 · cites it directly2descendants
- K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionMenicon Co, Ltd. · 2020 · 2 generations on1descendant
- K173538Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. · 2017 · cites it directly1descendant
- K112909OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting SoultionBausch & Lomb, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022687 | Aosept Clear Care Cleaning and Disinfecting Solution | Ciba Vision Corporation | 2002 | — |
| +1 | K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde | Alcon Laboratories, Inc. | 2015 | 1 |
| +1 | K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2016 | — |
| +2 | K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Menicon Co, Ltd. | 2020 | — |
| +1 | K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | Alcon Laboratories, Inc. | 2017 | — |
| +1 | K112909 | OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion | Bausch & Lomb, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 LYL? 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 LYL device
- #1 K211361 3N Contact Lenses Adjunct Cleanerscore 3.6 · 4 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | — | Allergan Ultracare Disinfecting Solution/Neutralizer Named without a submission number |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142284 | Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde | 2015 | 3 |
| K162597 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | 2016 | 2 |
| K173538 | Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc | 2017 | 1 |
| K112909 | OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Soultion | 2012 | 1 |
| K191795 | AOCup Lens Case with AODisc | 2019 | 0 |
| K111877 | EZS05 Cleaning and Disinfecting Solution, Bausch + Lomb EZS05 Cleaning and Disinfecting… | 2012 | 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, K142284 (Alcon Laboratories, Inc., 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LYL devicesLYL Accessories, Solution, Ultrasonic Cleaners For Lenses: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LYL
Too few LYL 510(k)s in any year since 2007 to give a median.
Recalls per year · LYL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYL
4in 2025
MAUDE reports naming product code LYL, 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 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 8 | 9 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 1 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AOSEPT Clear Care Cleaning and Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfecting,and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022687: Aosept Clear Care Cleaning and Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022687
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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