# K980649: Preference Standard, Preference Toric, Cooper Toric, Cooperclear, Cooperht, CB 43, Vantage, Vantage Accents

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: May 13, 1998 after 83 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- 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 no predicate by number.

## Indications for use
The Preference® standard, CooperClear™, CooperHT™, CV 43™, Vantage® and Vantage® Accents (tetrafilcon A) Hydrophilic Contact Lenses are indicated for daily wear by persons who exhibit astigmatism of 2.50 diopters or less that does not interfere with visual acuity. The PreferenceToric™ and Cooper Toric™ hydrophilic contact lenses are indicated for daily wear use by persons with non-diseased eyes that are myopic or hyperopic, who exhibit astigmatism up to 9.00 diopters and can obtain satisfactory visual acuity, in a spherical range of −20.00 to +12.00.

Source page: https://510kreport.com/device/K980649
Methodology: https://510kreport.com/methodology