NRJ — Ultrasound, Skin Permeation Class II
FDA product code NRJ covers "Ultrasound, Skin Permeation", a Class II medical device regulated under 21 CFR 878.4410. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040525 | sontra medical | SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D20 | August 17, 2004 |