510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NRJClass II

Ultrasound, Skin Permeation

21 CFR 878.4410 / General, Plastic Surgery
FDA source (opens on fda.gov)

NRJ is the FDA product code for Ultrasound, Skin Permeation, a class II device type, regulated under 21 CFR 878.4410. FDA's definition for this code reads: "Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NRJ
Device name
Ultrasound, Skin Permeation
FDA definition
Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
Regulation
21 CFR 878.4410
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code NRJ

By decision year
1 clearance under product code NRJ with a decision year between 2004 and 2004, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NRJ by decision year
YearClearances
20041

Applicants with the most clearances

Product code NRJ
Applicants holding the most 510(k) clearances under product code NRJ
ApplicantClearances
Sontra Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code