# K984573: Opti-Free Express Multi-Action Cleaning and Rewetting Drop

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Sep 16, 1999 after 267 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)
- P830034: Polyquat Disinfection System, Alcon Laboratories. FDA lists this PMA only through its supplements; the earliest we hold is P830034/S001 (Oct 22, 1985). Summary page 1.

## Indications for use
OPTI-FREE® EXPRESS® LENS DROPS may be used to lubricate and rewet daily, extended wear and disposable soft (hydrophilic) contact lenses as follows: Moistening lenses as needed during the day to reduce discomfort. Moistening extended wear lenses prior to retiring at night and upon awakening.

Source page: https://510kreport.com/device/K984573
Methodology: https://510kreport.com/methodology