NRJ
- Product code
- NRJ
- Device name
- Ultrasound, Skin Permeation
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4410
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
FDA classification definition
Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
Official FDA classification page: NRJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).