NRJ — Ultrasound, Skin Permeation Class II

FDA Device Classification

Classification Details

Product Code
NRJ
Device Class
Class II
Regulation Number
878.4410
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K040525sontra medicalSONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D20August 17, 2004