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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
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition THE DEVICE IS INTENDED TO TEMPORARILY ALTER THE APPEARANCE OF CELLULITE
Product CodeNUV
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
ALMA LASERS LTD.
  SUBSTANTIALLY EQUIVALENT 1
BICELLULASE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCELLULASE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELEME MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNERON
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 1
Total Device Problems 1

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