# K161622: LensGiene Sterile Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Optics Laboratory, Inc.
- Decided: Aug 11, 2016 after 59 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002319 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151768: Menicon Saline Rinse Solution, Menicon Co, Ltd. (2015) Summary page 4.
- K110221: Eye-Cept Sterile Saline Solution, Optics Laboratory, Inc. (2011) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K161622
Methodology: https://510kreport.com/methodology