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U.S. Department of Health and Human Services

Product Classification

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Device over the counter thermal treatment for acne.
Regulation Description Powered heating pad.
Definition For the treatment of mild to moderate inflammatory acne.
Physical State In addition to the device, there may be batteries, re-charger, USB cable
Technical Method Deliver heat to acne to kill propionibacterium acne virus
Target Area Acne/pimples
Regulation Medical Specialty Physical Medicine
Review Panel General & Plastic Surgery
Product CodeOZC
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 890.5740
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible