510(k) · Cleared
ClearedEye See Multipurpose Contact Lens Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lapis Lazuli International NV · LPN Accessories, Soft Lens Products
Cleared on Jul 24, 2007 as substantially equivalent to K051104 (Lapis Lazuli, NV, 2006) after a 126-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Jul 24, 2007
- Review
- 126 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030092 (2003). No later device cites it as a predicate yet.
- Root · 2 generations backK030092 Complete Brand Multi-Purpose SolutionAdvanced Medical Optics, Inc. · 2003
- 1 generation backK051104 Eye See Multipurpose, NO-Rub Contact Lens SolutionLapis Lazuli, NV · 2006
- This deviceK070767 Eye See Multipurpose Contact Lens SolutionLapis Lazuli International NV · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030092 | Complete Brand Multi-Purpose Solution | Advanced Medical Optics, Inc. | 2003 | — |
| −1 | K051104 | Eye See Multipurpose, NO-Rub Contact Lens Solution | Lapis Lazuli, NV | 2006 | — |
| 0 (this device) | K070767 | Eye See Multipurpose Contact Lens Solution | Lapis Lazuli International NV | 2007 | — |
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? (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 |
|---|---|---|---|
| * | K051104 | Eye See Multipurpose, NO-Rub Contact Lens SolutionSummary page 2…ange from 4 hour soak to a 10 Minute Express Disinfection, will be added to the Labeling and Directions for Use of Lapis Lazuli International's previously cleared 510(k) K051104- Lapis Lazuli International NV Co. Ltd proposes to market and sell in United States interstate commerce, The EYE SEETM Multipurp… | 2006 |
| * | — | Aquify Multi-Purpose Solution Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The EYE SEE™ Multipurpose Contact Lens Solution is indicated for use in the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage 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/K070767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070767: Eye See Multipurpose Contact Lens Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070767
Report an extraction error
Are you the manufacturer?
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