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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
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
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
2022 1 1
2025 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Retinal Injury 1 1
Flashers 1 1

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