Definition: For The Treatment Of Mild To Moderate Inflammatory Acne.
| Device Type ID | 5482 |
| Device Name | Over The Counter Thermal Treatment For 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 Description | Powered Heating Pad. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 890.5740 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5482 |
| Device | Over The Counter Thermal Treatment For Acne. |
| Product Code | OZC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Heating Pad. |
| CFR Regulation Number | 890.5740 [🔎] |