Cooper Medical Devices Corp.
United StatesFDA applicant, unverified
- Devices
- 7
What Cooper Medical Devices Corp. makes
Cooper Medical Devices Corp. manufactures ophthalmic surgical instruments and devices, including the Ocutome Model 8000 for corneal incision, the Charles Pneumatic Intraocular Scissors for precise tissue cutting, and the Landers and Sebestyen irrigating contact lenses for intraocular procedures. Their portfolio also includes the May Illuminated/Infusion PIC for cataract surgery, the Vabra Aspirator for vitreous removal, and protective eyewear labeled as The Protectors. These products are designed for use in corneal, cataract, and vitreous surgeries, as well as general eye protection.
The company’s devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance. They are listed in the FDA’s 510(k) database, indicating regulatory submission for market authorization. The manufacturer is based in the United States.
Catalogue
Ocutome Model 8000 Ref K791898
Regimes: 510(k) Registry: 510(k)Charles Pneumatic Intraocular Scissors Ref K801850
Regimes: 510(k) Registry: 510(k)Landers Contact Lens Ref K802971
Regimes: 510(k) Registry: 510(k)May Illuminated/Infusion Pic Ref K801411
Regimes: 510(k) Registry: 510(k)Sebestyen Irrigating Contact Lens Ref K802927
Regimes: 510(k) Registry: 510(k)Vabra Aspirator Ref K800833
Regimes: 510(k) Registry: 510(k)The Protectors Ref K801312
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cooper Medical Devices Corp. have in the registry?
The registry currently lists 7 devices for Cooper Medical Devices Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cooper Medical Devices Corp.'s devices?
Among its 7 most recently registered devices, Cooper Medical Devices Corp. has devices listed in FDA 510(k) (7 devices).
What risk classes do Cooper Medical Devices Corp.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Cooper Medical Devices Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cooper Medical Devices Corp. in the registry?
The most recently registered devices listed for Cooper Medical Devices Corp. include OCUTOME MODEL 8000, CHARLES PNEUMATIC INTRAOCULAR SCISSORS, LANDERS CONTACT LENS and MAY ILLUMINATED/INFUSION PIC.