FDA Product Code ONF: Powered Light Based Non-laser Surgical Instrument With Thermal Effect

A Light Based Non-laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (ipl). Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic. Indication For Use Can Be General And/or Specific.the Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Or Remove Tissue By The Light.

Leading manufacturers include Smedtrum Medical Technology Co., Ltd., El.En S.P.A. and Medicreations, LLC.