DeviceClearance

Product code NRJ— General, Plastic Surgery

SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000

Classification name
Ultrasound, Skin Permeation
Device class
Class 2
Regulation
21 CFR 878.4410
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NRJ under 21 CFR 878.4410, via openFDA

Market context for product code NRJ

FDA has cleared 1 device under product code NRJ, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NRJ

Recent clearances under product code NRJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.