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

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device electrosurgical coagulation for aesthetic
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition For the treatment of spider vein or telangiectasia by thermocoagulation.
Physical State Electrosurgical generator and needle electrodes
Technical Method High Frequency radio wave energy
Target Area small surface blood vessels
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeONQ
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch Two - Surgical (GSDB2)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

-
-