# K110221: Eye-Cept Sterile Saline Solution

- Pathway: 510(k) (Traditional)
- Applicant: Optics Laboratory, Inc.
- Decided: Nov 1, 2011 after 280 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: 2 generations back to K002319 (2000). 4 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 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 1.
- P790011: Unisol, Wesley Jessen Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P790011/S001 (Dec 31, 1980). Summary page 1.

## Most influential descendants
- K151768: Menicon Saline Rinse Solution (2015), 6 descendants of its own
- K170483: Bausch + Lomb Sensitive Eyes Plus Saline Solution (2017), 2 descendants of its own
- K201069: VibrantVue Scleral Saline (2020), 1 descendant of its own
- K193441: Aqua Naina Sterile Saline Solution (2020), 1 descendant of its own
- K221263: Aqua Naina Plus Sterile Saline Solution (2022), 0 descendants of its own

## Indications for use
Eye-Cept® Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and for wetting soft contact lenses after disinfection before use.

Source page: https://510kreport.com/device/K110221
Methodology: https://510kreport.com/methodology