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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeOHV
Regulation Number 878.4590
Device Class 2


Premarket Reviews
ManufacturerDecision
SYNERON
  SUBSTANTIALLY EQUIVALENT 3
ULTHERA, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 36
No Information 2
Improper or incorrect procedure or method 1
Total Device Problems 39

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