Neurosurgical Laser With Mr Thermography

Product Code: ONO

General & Plastic Surgery Medical Laser Products

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.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.4810

Radiation Type	Optical
Radition Safety	Product
Annual Reports	Yes

Products Classified as ONO

3825

Neurosurgical Laser With Mr Thermography

Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

3825

Neurosurgical Laser With Mr Thermography

Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Neurosurgical Laser With Mr Thermography [30278]	21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [38651]	21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [38649]	21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [38650]	21 CFR §878.4810 🔎
Neurosurgical Laser With Mr Thermography [34006]	21 CFR §878.4810 🔎

Pre-market Notifications for ONO

K214125	TRANBERG Thermoguide Therapy System	Clinical Laserthermia Systems AB
K211269	Visualase MRI-Guided Laser Ablation System (SW 3.4)	Medtronic Navigation, Inc.

Global Unique Device Identification Database

17340007000888	Neurosurgical Laser With Mr Thermography
17340007000871	Neurosurgical Laser With Mr Thermography
37340007000868	Neurosurgical Laser With Mr Thermography
37340007000851	Neurosurgical Laser With Mr Thermography
37340007000844	Neurosurgical Laser With Mr Thermography
17340007000833	Neurosurgical Laser With Mr Thermography
17340007000826	Neurosurgical Laser With Mr Thermography
00763000357504	Neurosurgical laser with MR thermography
00763000313364	Neurosurgical laser with MR thermography

Maude Adverse Events

THERMOGRAM

UNK

2017-05-11