# K974485: Sauflon All-in-One Light Contact Lens Solution

- Pathway: 510(k) (Traditional)
- Applicant: Szabocsik and Assoc.
- Decided: Feb 24, 1998 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bausch and Lomb ReNu Multipurpose Solution: named in the summary without a submission number

## Indications for use
The Sauflon Multipurpose Soft (hydrophilic) Contact Lens Solution is indicated for use in chemical (not heat) disinfection, daily cleaning, rinsing and storage of daily and extended wear soft contact lenses as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K974485
Methodology: https://510kreport.com/methodology