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U.S. Department of Health and Human Services

Product Classification
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Device neurosurgical laser with mr thermography
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
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.
Physical State Laser system under MRI guidance and MR thermography
Technical Method Laser energy to necrotize or coagulate brain tissue.
Target Area Brain tissue
Regulation Medical Specialty General & Plastic Surgery
Review Panel Neurology
Product CodeONO
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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