# K031193: Soft (Hydrophilic) Contact Lens Care Solution

- Pathway: 510(k) (Traditional)
- Applicant: Alcon, Inc.
- Decided: Jul 3, 2003 after 78 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: 1 generation back to P830034/S026 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P830034/S026: Opti-Free Rinsing,Disinfecting & Storage Solution, Alcon Laboratories (1995). A supplement to the PMA, as the summary prints it.

## Indications for use
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care practitioner. OPTI-ONE Multi-Purpose Solution (modified directions for use) can also be used as a diluent for OPTI-ZYME Enzymatic Cleaner.

Source page: https://510kreport.com/device/K031193
Methodology: https://510kreport.com/methodology