NRJ

Ultrasound, Skin Permeation

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NRJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).