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 (all years, FDA)

1 (all years; only the last 3 years are listed here)

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).