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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device massager, vacuum, light induced heating
Definition THE DEVICE IS INTENDED TO TEMPORARILY ALTER THE APPEARANCE OF CELLULITE
Product CodeNUV
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
B&M S.R.L. MARKETING NEL BENESSERE
  SUBSTANTIALLY EQUIVALENT 1
I-TECH INDUSTRIES SRL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 1 1

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