Definition: Indicated For The Temporary Disruption Of The Outer Layer Of Skin For The Application Of Drugs, Etc.
| Device Type ID | 5781 |
| Device Name | Ultrasound, Skin Permeation |
| Regulation Description | Low Energy Ultrasound Wound Cleaner. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4410 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NRJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5781 |
| Device | Ultrasound, Skin Permeation |
| Product Code | NRJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Low Energy Ultrasound Wound Cleaner. |
| CFR Regulation Number | 878.4410 [🔎] |