Product Classification

• 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 Code: OZC
• 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible