# K983973: Opti-One Multi-Purpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Dec 18, 1998 after 39 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 P860023/S012 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860023/S012: Bausch & Lomb (R) Renu (R) Multi-Purpose Solution, Bausch & Lomb, Inc. (1997). A supplement to the PMA, as the summary prints it.
- K974723: Renu Multiplus Multi-Purpose Solution, Bausch & Lomb, Inc. (1998) Summary page 1.

## Indications for use
For use in the daily cleaning, removing protein deposits, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye practitioner. For use as a diluent for OPTI-FREE® SUPRACLENS® Daily Protein Remover. OPTI-ONE® Multi-Purpose Solution can be used to dissolve OPTI-ZYME® Enzymatic Cleaning Tablets.

Source page: https://510kreport.com/device/K983973
Methodology: https://510kreport.com/methodology