# K052809: Sauflon Flat Coloured Lens Case

- Pathway: 510(k) (Traditional)
- Applicant: Sauflon Pharmaceuticals, Ltd.
- Decided: Nov 2, 2005 after 29 days
- Product code: LRX (Case, Contact Lens)
- 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 Lens Case: named in the summary without a submission number

## Indications for use
Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection.

Source page: https://510kreport.com/device/K052809
Methodology: https://510kreport.com/methodology