# K990480: Opti-Free Supraclens Daily Protein Remover

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: May 10, 1999 after 83 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: 2 generations back to P820001/S018 (1995). 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)
- K974625: Opti-Free Supraclens Daily Protein Remover, Alcon Laboratories (1998) Summary page 1.

## Indications for use
OPTI-FREE® SUPRACLENS® Daily Protein Remover is indicated for use with daily wear and extended wear soft (hydrophilic) contact lens or rigid gas permeable (silicone acrylate and fluorosilicone acrylate) lenses to simultaneously enzymatically clean them while they are being disinfected (soaked) in, OPTI-FREE® EXPRESS® Multi-Purpose Solution, OPTI-FREE® Rinsing, Disinfecting and Storage Solution, OPTI-ONE® Multi-Purpose Solution, Bausch & Lomb ReNu® Multi-Purpose Solution or conditioned in OPTI-SOAK® Conditioning Solution.. Use as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K990480
Methodology: https://510kreport.com/methodology