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U.S. Department of Health and Human Services

Product Classification
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Device static electricity-emitting device, cosmetic use
Definition Intended for relaxation and cosmetic use.
Physical State Hand held bulb and the bulb creates static electricity that is applied to the skin.
Technical Method Application of static electricity to skin.
Target Area Skin
Review Panel General & Plastic Surgery
Product CodeNZF
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
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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