Product Classification

• 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 Code: OHV
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 878.4590
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 12-280 IEC 62555 Edition 1.0 2013-11
  Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
• 12-281 IEC 60601-2-62 Edition 1.0 2013-07
  Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment

Guidance Document

• Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible