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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
BESHAPE TECHNOLOGIES , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLASSYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFWAVE MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 8
ULTHERA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2021 11 19
2022 12 12
2023 11 12
2024 11 11
2025 21 21
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Improper or Incorrect Procedure or Method 7 7
Insufficient Device Problem Information 6 6
Sparking 5 5
Break 2 2
Unintended Electrical Shock 2 2
Failure to Power Up 2 2
Fracture 2 2
Noise, Audible 2 2
No Display/Image 1 1
Off-Label Use 1 1
Physical Resistance/Sticking 1 1
Image Display Error/Artifact 1 1
Smoking 1 1
Scratched Material 1 1
Key or Button Unresponsive/not Working 1 1
Use of Device Problem 1 1
Dent in Material 1 1
Computer Operating System Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15 16
Scar Tissue 13 13
Deformity/ Disfigurement 11 11
Burn(s) 11 11
No Clinical Signs, Symptoms or Conditions 8 16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 7 7
Insufficient Information 7 7
Nerve Damage 7 7
Superficial (First Degree) Burn 6 6
Erythema 6 6
Skin Discoloration 6 6
Swelling/ Edema 5 5
Wheal(s) 4 4
Headache 4 4
Muscle Weakness/Atrophy 3 3
Neuropathy 3 3
Bruise/Contusion 3 3
Visual Impairment 3 4
Emotional Changes 3 3
Nodule 3 4
Hyperpigmentation 3 3
Dry Eye(s) 3 3
Unspecified Tissue Injury 3 3
Burning Sensation 3 3
Partial thickness (Second Degree) Burn 3 3
Paresis 2 2
Dyspnea 2 2
Vitreous Floaters 2 2
Blurred Vision 2 2
Tissue Breakdown 2 2
Hypopigmentation 2 2
Electric Shock 2 2
Full thickness (Third Degree) Burn 2 2
Urticaria 2 2
Skin Tears 1 1
Loss of Vision 1 1
Unspecified Vascular Problem 1 1
Subcutaneous Nodule 1 1
Sensitivity of Teeth 1 1
Nervous System Injury 1 1
Wrinkling 1 1
Undesired Nerve Stimulation 1 1
Pyogenic Infection 1 1
Distress 1 1
Skin Burning Sensation 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Salivary Gland Problem 1 1
Unspecified Eye / Vision Problem 1 1
Vomiting 1 1
Vertigo 1 1

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