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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
Definition Skin resurfacing
Product CodeOUH
Regulation Number 878.4400
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Burn 1 1
Erythema 1 1
Visual Impairment 1 1
Deformity/ Disfigurement 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesthetics Biomedical, Inc. II Nov-12-2020
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