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U.S. Department of Health and Human Services

Product Classification

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Device focused ultrasound for tissue heat or mechanical cellular disruption
Regulation Description Focused ultrasound stimulator system for aesthetic use.
Definition A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.
Physical State ultrasound
Technical Method Use of focused ultrasound
Target Area soft tissue
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOHV
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type 510(k)
Regulation Number 878.4590
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use
Third Party Review Not Third Party Eligible
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