• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device over the counter thermal treatment for acne.
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 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
-
-