Ultrasound, Skin Permeation
The Skin Permeation Ultrasound device uses low-frequency ultrasound energy to temporarily disrupt the outer layer of the skin, enabling the transdermal application of drugs or other substances. This technology, known as sonophoresis, facilitates drug delivery through skin without needles. It is an FDA Class 2 device regulated under 21 CFR 878.4410 in the General and Plastic Surgery specialty, with product code NRJ, requiring 510(k) clearance. Third-party 510(k) review is available for this device. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NRJ
- Device Class
- FDA class 2
- Regulation Number
- 878.4410
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040525 | SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 | Aug 17, 2004 | Unknown | Sontra Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.