FDA Product Code ONG: Powered Laser Surgical Instrument With Microbeamfractional Output
A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. 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, Remove Or Coagulate Tissue By The Light.
Leading manufacturers include Avava, Inc., Shanghai Apolo Medical Technology Co., Ltd. and Paradigm Medical Corporation.
FDA 510(k) Cleared Powered Laser Surgical Instrument With Microbeamfractional Output Devices (Product Code ONG)
About Product Code ONG - Regulatory Context
510(k) Submission Activity
35 total 510(k) submissions under product code ONG since 2009, with 35 receiving FDA clearance (average review time: 168 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under ONG have taken an average of 117 days to reach a decision - down from 175 days historically, suggesting improved FDA processing for this classification.
ONG devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →