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FDA PRODUCT CODE · CLASS II

ONO — Neurosurgical Laser With Mr Thermography

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4810
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K260976Monteris Medical · 510k2026-04-23
K253391Medtronic Navigation, Inc. · 510k2026-03-13
K251298Clinical Laserthermia Systems, AB · 510k2025-09-04
K250307Medtronic Navigation · 510k2025-05-29

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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