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 |