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Neurosurgical Laser With Mr Thermography

FDA product code ONO · 8 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4810
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2022-01-07 – 2026-09-03

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.

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