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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fat reducing low level laser
Definition Non-invasive reduction in fat layer for body contouring
Product CodeOLI
Regulation Number 878.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOPHOTAS INC
  SUBSTANTIALLY EQUIVALENT 1
CONTOUR RESEARCH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ERCHONIA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
IR TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
RESURGEONZ LLC
  SUBSTANTIALLY EQUIVALENT 1
WARD PHOTONICS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 2 2
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Product Quality Problem 2 2
Use of Device Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn, Thermal 3 3
Superficial (First Degree) Burn 3 3
Partial thickness (Second Degree) Burn 1 1
Cancer 1 1
Pain 1 1

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