# K083812: Refresh Optive Lens Comfort Rewetting Drops

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Jul 9, 2009 after 199 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 P910075/S007 (1996). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992028: Refresh Contacts Lubricating and Rewetting Drops, Allergan, Inc. (1999) Summary page 1.

## Most influential descendants
- K190674: REFRESH RELIEVA For CONTACTS (2019), 0 descendants of its own

## Indications for use
Use REFRESH® OPTIVETM Contacts Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable (RGP) contact lenses, to help relieve dryness, discomfort, and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the lens prior to insertion on the eye.

Source page: https://510kreport.com/device/K083812
Methodology: https://510kreport.com/methodology