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U.S. Department of Health and Human Services

Product Classification
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Device stimulator, electrical, transcutaneous, for diabetic retinopathy
Definition Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina.
Physical State Electrical stimulation unit with leads and cutaneous electrodes
Technical Method Applies an electrical current through electrodes on a patient's eyelid (skin)
Target Area Eyelid
Review Panel Ophthalmic
Product CodeOXW
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
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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