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 El.En S.P.A., Smedtrum Medical Technology Co., Ltd. and Medicreations, LLC.
FDA 510(k) Cleared Powered Light Based Non-laser Surgical Instrument With Thermal Effect Devices (Product Code ONF)
About Product Code ONF - Regulatory Context
510(k) Submission Activity
73 total 510(k) submissions under product code ONF since 2008, with 73 receiving FDA clearance (average review time: 142 days).
Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 11 in the prior period.
FDA Review Time
Recent submissions under ONF have taken an average of 249 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
ONF devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →