# K991620: Visine for Contacts

- Pathway: 510(k) (Traditional)
- Applicant: Pfizer, Inc.
- Decided: Sep 24, 1999 after 136 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)
- None. The FDA summary names its predicate without a number.
- (no number) Lens Express/Lubricant Drops - Paco: named in the summary without a submission number
- (no number) Clear Eyes CLR - Ross Products: named in the summary without a submission number

## Indications for use
VISINE FOR CONTACTS Rewetting Drops may be used with daily and extended wear soft (hydrophilic) contact lenses for the following: Moistening of daily wear soft lenses while on the eyes during the day Moistening of extended wear soft lenses upon awakening and as needed during the day Moistening of extended wear soft lenses prior to retiring at night Placing 1 or 2 drops of VISINE FOR CONTACTS Rewetting Drops on the eye followed by blinking 2 or 3 times will relieve minor irritation, discomfort and blurring which may occur while wearing lenses.

Source page: https://510kreport.com/device/K991620
Methodology: https://510kreport.com/methodology