• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device laser for disruption of adipocyte cells for aesthetic use
Regulation Description Low level laser system for aesthetic use
Definition Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Product CodePKT
Regulation Number 878.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
CYNOSURE, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 1
Total Device Problems 1

-
-