ONO

Neurosurgical Laser With Mr Thermography

Product code

ONO

Device name

Neurosurgical Laser With Mr Thermography

Device class

Class 2

21 CFR

21 CFR 878.4810

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

5

Summaries archived here

5 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.

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: 2026-04-23.

5 summaries are archived here for direct download.