Product code ONO

Device name

Neurosurgical Laser With Mr Thermography

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4810

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset