# K011914: HYDRO2, HS-75

- Pathway: 510(k) (Traditional)
- Applicant: Innovision, Inc.
- Decided: Jul 27, 2001 after 38 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The bifocal/multifocal designs of the HYDRO; (filofocon A) contact lens are indicated for daily wear correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic. The lens may be disinfected with chemical disinfection only.

Source page: https://510kreport.com/device/K011914
Methodology: https://510kreport.com/methodology