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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laser assisted lipolysis
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Intended to be used for laser assisted lipolysis
Product CodeORK
Regulation Number 878.4810
Device Class 2

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Flare or Flash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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