ONG

Powered Laser Surgical Instrument With MicrobeamFractional Output

Product code

ONG

Device name

Powered Laser Surgical Instrument With MicrobeamFractional Output

Device class

Class 2

21 CFR

21 CFR 878.4810

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

5

Summaries archived here

4 (direct download)

510(k) clearances (all years, FDA)

35 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2025-10-20.

4 summaries are archived here for direct download.