NRJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ultrasound, Skin Permeation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4410
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 (K040525) | Sontra Medical, Inc. | 2004-08-17 |
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