Laser, Neurosurgical

Device Code: 3833

Product Code(s): LKW

Device Classification Information

• Device Type ID: 3833
• Device Name: Laser, Neurosurgical
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
• Submission Type: Contact ODE
• FDA Device Classification: Class 3 Medical Device
• Product Code: LKW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-268 IEC 60601-2-22 Edition 3.1 2012-10
  Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
• 12-273 IEC 60825-1 Edition 2.0 2007-03
  Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

Total Product Life Cycle

• Device Type ID: 3833
• Device: Laser, Neurosurgical
• Product Code: LKW
• FDA Device Classification: Class 3 Medical Device

TPLC Last Update: 2019-04-02 20:38:02