# K201069: VibrantVue Scleral Saline

- Pathway: 510(k) (Traditional)
- Applicant: Dry Eye Innovations, LLC
- Decided: Jul 31, 2020 after 100 days
- Product code: MRC (Products, Contact Lens Care, Rigid Gas Permeable)
- Device class: 2
- Regulation: 21 CFR 886.5918
- 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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 5.

## Most influential descendants
- K221263: Aqua Naina Plus Sterile Saline Solution (2022), 0 descendants of its own

## Indications for use
The VibrantVue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) 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/K201069
Methodology: https://510kreport.com/methodology