Medical Device Manufacturer · GB , Southampton

CooperVision, Inc. - FDA 510(k) Cleared Devices

97 submissions · 94 cleared · Since 1978
97
Total
94
Cleared
0
Denied

CooperVision, Inc. is a contact lens manufacturer based in Southampton, GB. The company specializes in ophthalmic devices for vision correction.

CooperVision has received 94 FDA 510(k) clearances from 97 total submissions since its first clearance in 1978. Ophthalmic devices represent 88% of the company's regulatory submissions. The company remains active, with its latest FDA 510(k) clearance in 2024.

Recent cleared devices include daily disposable contact lenses in spheric, toric, and multifocal designs. Notable product families include MyDay, Clariti 1 day, Biofinity, and Avaira Vitality. These lenses feature various material compositions and UV-blocking technology.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - CooperVision, Inc.
97 devices
1-12 of 97

Looking for a specific device from CooperVision, Inc.? Search by device name or K-number.

Search all CooperVision, Inc. devices
Filters