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U.S. Department of Health and Human Services

Product Classification
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Device knife, intraocular pressure lowering
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma
Physical State manual, non-powered, knife
Technical Method Uses a manual, non-powered, knife to cut trabecular meshwork
Target Area trabecular meshwork
Regulation Medical Specialty General & Plastic Surgery
Review Panel Ophthalmic
Product CodeQUQ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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