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U.S. Department of Health and Human Services

Product Classification
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Device ultrasound, cyclodestructive
Regulation Description Ultrasound cyclodestructive device.
Definition An ultrasound cyclodestructive device uses high intensity focused ultrasound (HIFU) energy to create lesions in the ciliary body and/or trabecular meshwork to reduce intraocular pressure in glaucoma patients.
Physical State An ultrasound transducer assembly, support arm and electronic control unit.
Technical Method Creation of high intensity focused ultrasound (HIFU) energy.
Target Area Ciliary body and/or trabecular meshwork.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLZR
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.5350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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