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U.S. Department of Health and Human Services

Product Classification

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Device ultrasound, skin permeation
Regulation Description Low energy ultrasound wound cleaner.
Definition Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeNRJ
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4410
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible