510(k) K040525
K040525 is an FDA 510(k) premarket notification submitted by Sontra Medical, Inc. for the device "SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000". The FDA issued a decision of Substantially Equivalent (kit) on August 17, 2004. The device falls under product code NRJ (Ultrasound, Skin Permeation), a Class II device regulated under 21 CFR 878.4410. Sontra Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- August 17, 2004
- Date Received
- March 1, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound, Skin Permeation
- Device Class
- Class II
- Regulation Number
- 878.4410
- Review Panel
- SU
- Submission Type
Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.