# K990606: Tetrafilcon a

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Mar 15, 1999 after 20 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 its predicate without a number.
- (no number) post-hydration tinted lenses: named in the summary without a submission 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 for the correction of visual acuity by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lenses can be worn 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 not-aphakic 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/K990606
Methodology: https://510kreport.com/methodology