510(k) · Cleared
ClearedLensGiene Sterile Saline Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optics Laboratory, Inc. · LPN Accessories, Soft Lens Products
Cleared on Aug 11, 2016 as substantially equivalent to K151768 (Menicon Co, Ltd., 2015) and 1 other predicate after a 59-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Aug 11, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- LPN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002319 (2000). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK002319 Purilens Saline SolutionPurilens, Inc. · 2000
- 3 generations backK093367 Sterile Saline SolutionCachet Pharmaceuticals Pvt., Ltd. · 2010
- 2 generations backK110221 Eye-Cept Sterile Saline SolutionOptics Laboratory, Inc. · 2011
- 1 generation backK151768 Menicon Saline Rinse SolutionMenicon Co, Ltd. · 2015
- This deviceK161622 LensGiene Sterile Saline SolutionOptics Laboratory, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002319 | Purilens Saline Solution | Purilens, Inc. | 2000 | — |
| −3 | K093367 | Sterile Saline Solution | Cachet Pharmaceuticals Pvt., Ltd. | 2010 | — |
| −2 | K110221 | Eye-Cept Sterile Saline Solution | Optics Laboratory, Inc. | 2011 | — |
| −1 | K151768 | Menicon Saline Rinse Solution | Menicon Co, Ltd. | 2015 | — |
| 0 (this device) | K161622 | LensGiene Sterile Saline Solution | Optics Laboratory, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (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 |
|---|---|---|---|
| * | K151768 | Menicon Saline Rinse SolutionSummary page 4…Panel: Ophthalmic Predicate Devices: The LensGiene™ Sterile Saline Solution is substantially equivalent to the Menicon Co., Ltd. Saline Rinse Solution (K151768) and the Optics Laboratory, Inc. EyeCept™ Sterile Saline Solution (K110221). Device Description: The LensGiene™ Sterile Salin… | 2015 |
| * | K110221 | Eye-Cept Sterile Saline SolutionSummary page 4…Saline Solution is substantially equivalent to the Menicon Co., Ltd. Saline Rinse Solution (K151768) and the Optics Laboratory, Inc. EyeCept™ Sterile Saline Solution (K110221). Device Description: The LensGiene™ Sterile Saline Solution is a sterile, preservative-free, aqueous solution of sodium chlo… | 2011 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 5 ancestors has a recall.
- 3 other devices also cite its predicate K151768.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 LensGiene™ Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The LensGiene™ Sterile Saline Solution is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161622: LensGiene Sterile Saline Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161622
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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