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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
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFWAVE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
SYNERON MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
SYNERON MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
ULTHERA, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 29 29
2017 29 29
2018 10 10
2019 15 15
2020 6 6
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 59 59
Insufficient Information 18 18
Patient-Device Incompatibility 6 6
Off-Label Use 6 6
Improper or Incorrect Procedure or Method 5 5
Device Operates Differently Than Expected 4 4
Sparking 2 2
Inaccurate Information 1 1
Output Problem 1 1
Temperature Problem 1 1
Expiration Date Error 1 1
Defibrillation/Stimulation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 20 20
Tissue Damage 15 15
Nerve Damage 10 10
Edema 8 8
Swelling 8 8
Burn, Thermal 8 8
Scar Tissue 7 7
Scarring 7 7
Bruise/Contusion 7 7
Erythema 6 6
Headache 6 6
No Code Available 6 6
Numbness 5 5
Inflammation 5 5
Emotional Changes 5 5
Burn(s) 5 5
Dry Eye(s) 5 5
Loss of Vision 5 5
Depression 5 5
Injury 4 4
Visual Impairment 4 4
Skin Discoloration 4 4
Facial Nerve Paralysis 4 4
Fatigue 4 4
Deformity/ Disfigurement 4 4
Partial thickness (Second Degree) Burn 4 4
Full thickness (Third Degree) Burn 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Eye Injury 3 3
Muscle Spasm(s) 3 3
Local Reaction 3 3
Skin Irritation 3 3
Hair Loss 3 3
Brain Injury 3 3
Anxiety 3 3
Complaint, Ill-Defined 3 3
Hypoesthesia 2 2
Blurred Vision 2 2
Dizziness 2 2
Seizures 2 2
Tinnitus 2 2
Autoimmune Disorder 2 2
Dyspnea 2 2
Patient Problem/Medical Problem 2 2
Loss of consciousness 1 1
Sensitivity of Teeth 1 1
Shaking/Tremors 1 1
Unspecified Tissue Injury 1 1
Dysphagia/ Odynophagia 1 1
Cellulitis 1 1
Adhesion(s) 1 1
Anemia 1 1
Flashers 1 1
Vitreous Floaters 1 1
Bone Fracture(s) 1 1
Red Eye(s) 1 1
Respiratory Distress 1 1
Paresis 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Neuropathy 1 1
Optical Nerve Damage 1 1
Muscle Weakness 1 1
Irritation 1 1
Left Ventricular Failure 1 1
Hearing Loss 1 1
Hematoma 1 1
Unspecified Infection 1 1
Vasoconstriction 1 1
Visual Disturbances 1 1
Burning Sensation 1 1
Tingling 1 1
Twitching 1 1
Scar Excision 1 1
Disability 1 1
Reaction 1 1
Hernia 1 1
Radiation Sickness Syndrome 1 1
Electric Shock 1 1
Weight Changes 1 1
Wrinkling 1 1
Ptosis 1 1
Osteopenia/ Osteoporosis 1 1
Tissue Breakdown 1 1
Superficial (First Degree) Burn 1 1

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