Neurosurgical Laser With Mr Thermography

ONO · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4810

Classification

FDA Product Code: ONO
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4810
Review panel: NE
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 7

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown