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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transparent patch for use in treatment of tattoos
Definition To reduce formation of bubbles during laser treatment of tattoos.
Product CodePKO
Regulation Number 878.4810
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Flashers 1 1
Necrosis 1 1
Scarring 1 1
Visual Impairment 1 1

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