# K991125: Sauflon Aerotab Disinfecting System for the Disinfection of Soft (Hydrophilic) Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Sauflon Pharmaceuticals, Ltd.
- Decided: Sep 14, 1999 after 165 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)
- P890059: PD 1343 Disinfecting Tablet, Alcon Laboratories. FDA lists this PMA only through its supplements; the earliest we hold is P890059/S001 (Dec 13, 1994). Summary page 1.

## Indications for use
The preservative-free SAUFLON AEROTAB DISINFECTING SYSTEM is indicated for chemical disinfection and storage of clear (untinted) soft (hydrophilic) contact lenses. The AEROSOLV UNPRESERVED BUFFERED SALINE is indicated for the rinsing of soft contact lenses after cleaning, dissolving of the AEROTAB tablet to make the disinfecting/ storage solution, and rinsing of the soft contact lenses prior to insertion onto the eye. The SAUFLON Barrel Lens Case is to be used with the AEROSOLV UNPRESERVED BUFFERED SALINE and Sauflon AEROTAB Disinfecting Tablets as the lens case for chemical disinfection and storage of clear, untinted soft (hydrophilic) contact lenses. The SAUFLON Barrel Lens Case may also be used as the lens case for storage of soft (hydrophilic) contact lenses during chemical disinfection only. DO NOT USE WITH HEAT OR HYDROGEN PEROXIDE SYSTEMS.

Source page: https://510kreport.com/device/K991125
Methodology: https://510kreport.com/methodology