ONG · Class II · 21 CFR 878.4810

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 Lutronic Corporation.

1
Total
1
Cleared
212d
Avg days
2025
Since

List of Powered Laser Surgical Instrument With Microbeamfractional Output devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Jul 31, 2025
eCO2 3D
K244060
Lutronic Corporation
General & Plastic Surgery · 212d

How to use this database

This page lists all FDA 510(k) submissions for Powered Laser Surgical Instrument With Microbeamfractional Output devices (product code ONG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →