510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONOClass II

Neurosurgical Laser With Mr Thermography

21 CFR 878.4810 / General, Plastic Surgery
FDA source (opens on fda.gov)

ONO is the FDA product code for Neurosurgical Laser With Mr Thermography, a class II device type, regulated under 21 CFR 878.4810. FDA's definition for this code reads: "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". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
ONO
Device name
Neurosurgical Laser With Mr Thermography
FDA 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.
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
1

Clearances, product code ONO

By decision year
8 clearances under product code ONO with a decision year between 2022 and 2026, 2026 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code ONO by decision year
YearClearances
20222
20241
20252
20263

Applicants with the most clearances

Product code ONO
Applicants holding the most 510(k) clearances under product code ONO
ApplicantClearances
Medtronic Navigation, Inc3
Clinical Laserthermia Systems AB2
Monteris Medical Corp2
Monteris Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code