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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
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
BESHAPE TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLASSYS INC
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFWAVE MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SOFWAVE MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 7
ULTHERA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 6 6
2021 11 11
2022 12 12
2023 10 10
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Improper or Incorrect Procedure or Method 6 6
Insufficient Information 6 6
Off-Label Use 4 4
Sparking 4 4
Patient-Device Incompatibility 4 4
Unintended Electrical Shock 2 2
Use of Device Problem 2 2
Failure to Power Up 2 2
Noise, Audible 2 2
Output Problem 1 1
Scratched Material 1 1
Defibrillation/Stimulation Problem 1 1
Inaccurate Information 1 1
Computer Operating System Problem 1 1
Dent in Material 1 1
Image Display Error/Artifact 1 1
No Display/Image 1 1
Key or Button Unresponsive/not Working 1 1
Expiration Date Error 1 1
Energy Output Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 20 20
Scar Tissue 11 11
Burn(s) 9 9
Skin Discoloration 8 8
Nerve Damage 8 8
Deformity/ Disfigurement 8 8
Erythema 7 7
Emotional Changes 6 6
Tissue Damage 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Partial thickness (Second Degree) Burn 4 4
Wheal(s) 4 4
Superficial (First Degree) Burn 4 4
Bruise/Contusion 4 4
Edema 4 4
Neuropathy 4 4
Swelling 4 4
Scarring 3 3
Visual Impairment 3 3
Inflammation 3 3
Muscle Spasm(s) 3 3
Headache 3 3
Dyspnea 3 3
Brain Injury 3 3
Swelling/ Edema 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Tissue Injury 2 2
Dizziness 2 2
Blurred Vision 2 2
Urticaria 2 2
Complaint, Ill-Defined 2 2
Injury 2 2
Hypoesthesia 2 2
Numbness 2 2
Electric Shock 2 2
No Code Available 2 2
Dry Eye(s) 2 2
Autoimmune Disorder 2 2
Vitreous Floaters 2 2
Fatigue 2 2
Muscle Weakness 2 2
Unspecified Infection 2 2
Paresis 2 2
Loss of Vision 2 2
Tinnitus 2 2
Seizures 1 1
Visual Disturbances 1 1
Tingling 1 1
Respiratory Distress 1 1
Undesired Nerve Stimulation 1 1
Flashers 1 1
Eye Injury 1 1
Facial Nerve Paralysis 1 1
Hematoma 1 1
Anemia 1 1
Dysphagia/ Odynophagia 1 1
Encephalopathy 1 1
Paresthesia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Eye / Vision Problem 1 1
Salivary Gland Problem 1 1
Difficulty Chewing 1 1
Blister 1 1
Localized Skin Lesion 1 1
Skin Infection 1 1
Nodule 1 1
Pyogenic Infection 1 1
Ptosis 1 1
Osteopenia/ Osteoporosis 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
Nervous System Injury 1 1
Radiation Sickness Syndrome 1 1
Loss of consciousness 1 1
Sensitivity of Teeth 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Burn, Thermal 1 1
Depression 1 1
Disability 1 1
Reaction 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 RoyalVibe Health Ltd. II Oct-06-2023
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