# K014162: Modification to Optimum Cleaning, Disinfecting and

- Pathway: 510(k) (Special)
- Applicant: Lobob Laboratories, Inc.
- Decided: Jan 15, 2002 after 27 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: 1 generation back to K001964 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001964: Optimum Cleaning, Disinfecting and Storage Solution, Lobob Laboratories, Inc. (2000)

## Indications for use
To clean, disinfect and store fluorosilicone acrylate and silicone acrylate rigid gas permeable (RGP) and hard contact lenses

Source page: https://510kreport.com/device/K014162
Methodology: https://510kreport.com/methodology