FDA product code NRJ: Ultrasound, Skin Permeation
NRJ is the FDA product code for ultrasound, skin permeation. It is a Class II device, regulated under 21 CFR 878.4410 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under NRJ. The average 510(k) review took 169 days (median 169).
Definition
Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound, Skin Permeation |
| Device class | Class II |
| Regulation | 21 CFR 878.4410 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NRJ clearance
Top NRJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sontra Medical, Inc. | 1 | 2004-08-17 |
Most recent NRJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040525 | Sontra Medical, Inc. | SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 | 2004-08-17 | 169 |
Recalls for NRJ devices
openFDA lists no recalls for product code NRJ.
Frequently asked questions
What is FDA product code NRJ?
NRJ is the FDA product code for ultrasound, skin permeation. It is a Class II device, regulated under 21 CFR 878.4410 and reviewed by the General and Plastic Surgery panel.
What device class is NRJ?
Class II, regulation 21 CFR 878.4410. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRJ?
Across 1 cleared submissions the average was 169 days from receipt to decision (median 169).
Which companies have the most NRJ clearances?
Sontra Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NRJ
- Run a recall and safety report across every NRJ manufacturer
- Watch product code NRJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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