# K130734: Sauflon Multipurpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Sauflon Pharmaceuticals, Ltd.
- Decided: May 15, 2013 after 58 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 K021635 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050250: Aquify Multipurpose Solution, Ciba Vision Corporation (2005) Summary page 1.
- K033608: Aquify Multi-Purpose Solution, Ciba Vision Corporation (2004) Summary page 1.

## Indications for use
Sauflon Multipurpose Solution is indicated for use in the daily cleaning, rinsing, disinfection, removal of proteins, storage and conditioning of soft (hydrophilic) contact lenses including silicone hydrogel lenses, as recommended by the eye care practitioner

Source page: https://510kreport.com/device/K130734
Methodology: https://510kreport.com/methodology