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U.S. Department of Health and Human Services

Product Classification

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Device apparatus, cautery, radiofrequency, battery-powered
Regulation Description Radiofrequency electrosurgical cautery apparatus.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeHQQ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.4100
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
Accredited Persons
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