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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device skin resurfacing rf applicator
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Skin resurfacing
Product CodeOUH
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2025 3 3
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2 2
Scar Tissue 2 2
Swelling/ Edema 2 2
Emotional Changes 1 1
Device Overstimulation of Tissue 1 1
Unspecified Blood or Lymphatic problem 1 1
Ptosis 1 1
Nerve Damage 1 1
Visual Impairment 1 1
Deformity/ Disfigurement 1 1
Neuralgia 1 1
Bruise/Contusion 1 1

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