Not currently registered with FDA under this name

CooperVision, Inc.

Southampton, United Kingdom. Named as applicant on 1 dental 510(k) clearance between 1984 and 1984. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 11984–1984
Markets registered in: 532 registrations outside the US
Establishments: 0—

510(k) clearances per year, 1980–2026

Registered in 5 markets

Where regulators' registries name CooperVision, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United KingdomOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	CooperVision, Inc.	1 clearances	1984–1984	Below
Peru	DIGEMID	Manufacturer	COOPERVISION	23	2024–2025	Pure Global AI
Colombia	INVIMA	Registration holder	COOPER VISION INC	6	—	Pure Global AI
South Korea	MFDS	Manufacturer	Cooper Vision Inc.Cooper Vision, Inc	2	2000–2004	Pure Global AI
Israel	AMAR	Manufacturer	COOPERVISION INC.	1	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names CooperVision, Inc. as the applicant.

Decided	510(k)	Device	Device type
16 Mar 1984	K840141	DENTAL ULTRASONIC SCALER/ENDOSONIC	ELC Ultrasonic Scaler

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.