- Physicians Office Resource

VCLAS 9735560 .4MM CORE FIBER 10MM TIP
Visualase - 9735560

Device Description

An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Environmental Conditions

No Data Available

Device Sizes

Length: 10.0 Millimeter

Length: 10.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: ONO

Device Name: Neurosurgical Laser With Mr Thermography

Device Class: 2

Physical State: Laser system under MRI guidance and MR thermography

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.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Laser energy to necrotize or coagulate brain tissue.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Brain tissue

Regulation Number: 878.4810

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 00643169611993

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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