# K130805: Menicon Unique PH Multi-Purpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Jul 3, 2013 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: 1 generation back to K000148 (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)
- K000148: RGP Multi-Purpose Solution ID 100136, Alcon Laboratories (2000) Summary page 1.

## Indications for use
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permecable contact lenses.

Source page: https://510kreport.com/device/K130805
Methodology: https://510kreport.com/methodology
