# K151768: Menicon Saline Rinse Solution

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Aug 28, 2015 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: 3 generations back to K002319 (2000). 5 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093367: Sterile Saline Solution, Cachet Pharmaceuticals Pvt., Ltd. (2010) Summary page 4.
- K110221: Eye-Cept Sterile Saline Solution, Optics Laboratory, Inc. (2011) Summary page 4.

## Most influential descendants
- K170483: Bausch + Lomb Sensitive Eyes Plus Saline Solution (2017), 2 descendants of its own
- K201069: VibrantVue Scleral Saline (2020), 1 descendant of its own
- K221263: Aqua Naina Plus Sterile Saline Solution (2022), 0 descendants of its own
- K180319: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution (2018), 0 descendants of its own
- K173089: Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions (2017), 0 descendants of its own

## Indications for use
The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The Menicon Saline Rinse 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/K151768
Methodology: https://510kreport.com/methodology