# K013204: Aquify Lens Comfort Drops

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Vision Corporation
- Decided: Apr 3, 2002 after 190 days
- Product code: MRC (Products, Contact Lens Care, Rigid Gas Permeable)
- Device class: 2
- Regulation: 21 CFR 886.5918
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) ReNu Multiplus Lubricating and Rewetting Drops: named in the summary without a submission number
- (no number) Visine for Contacts: named in the summary without a submission number
- (no number) Hylashield CL Lubricating Eye Drops: named in the summary without a submission number

## Most influential descendants
- K032481: Theratears Contact Lens Comfort Drops (2003), 0 descendants of its own

## Recalls of this device
- Nov 2, 2005 · Not classified · Z-0182-06: Lack of assurance of sterility at the time of manufacture.

## Indications for use
Use AQuify Lens Comfort Drops to moisten, cushion, refresh, and provide temporary relief from dryness and irritation associated with contact lens wearing.

Source page: https://510kreport.com/device/K013204
Methodology: https://510kreport.com/methodology