Cooper Medical Corp.
US Last updated 23 May 2026
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- Devices
- 5
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Argon Laser Sys-Model 5000 Ref K832703
Argon Laser Surgical System 770 Ref K833387
Yag Laser 8000 Gastrointestinal Blee Ref K840144
Monitor CO2 Laser System Ref K820261
Cooper Medical Model 770 Ref K833497
FDA establishments
- Cooper Medical, SRL La Garita Alajuela · CR FEI 3014295858
What Cooper Medical Corp. makes
Cooper Medical Corp. manufactures laser systems for surgical and gastrointestinal procedures, including argon laser systems (e.g., Model 5000 and 770), YAG laser systems for gastrointestinal bleeding, and CO₂ laser systems with integrated monitoring.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class II and Class III. The company’s products are listed in the FDA’s 510(k) database and are based in the United States.
Frequently asked questions
What types of medical devices does Cooper Medical Corp. manufacture?
Cooper Medical Corp. specializes in laser systems designed for surgical and gastrointestinal applications. Their portfolio includes argon laser systems (such as the Model 5000 and 770), YAG laser systems for treating gastrointestinal bleeding, and CO₂ laser systems with integrated monitoring capabilities. These devices are engineered for precision in medical procedures.
Where is Cooper Medical Corp. based, and how does that affect its regulatory standing?
Cooper Medical Corp. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including the 510(k) clearance process for market authorization. The FDA’s 510(k) database lists these devices, reflecting their compliance with U.S. medical device requirements.
Which regulatory registries or databases list Cooper Medical Corp.’s devices?
Cooper Medical Corp.’s devices are included in the FDA’s 510(k) database, which serves as a public record of cleared medical devices in the United States. This registry is used to verify that individual devices have undergone the necessary premarket review process to ensure safety and effectiveness before commercial distribution.
How are Cooper Medical Corp.’s devices classified under FDA regulations?
Cooper Medical Corp.’s devices fall under both Class II and Class III classifications under FDA regulations. Class II devices generally pose moderate risk and require special controls beyond general controls, while Class III devices are considered high-risk and require premarket approval (PMA) due to insufficient data from general or special controls to assure safety and effectiveness. The specific classification depends on the device’s intended use and potential risks.
Information
- Country
- US