System, Laser, Photodynamic Therapy

Device Code: 5942

Product Code(s): MVF

Device Classification Information

• Device Type ID: 5942
• Device Name: System, Laser, Photodynamic Therapy
• Review Panel: General & Plastic Surgery
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Surgical Devices (DSD); General Surgery Devices Branch One - Light Based/Laser (GSDB1)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MVF
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 12-242 IEC 60601-2-57 Edition 1.0 2011-01
  Medical Electrical Equipment - Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/aesthetic Use
• 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: 5942
• Device: System, Laser, Photodynamic Therapy
• Product Code: MVF
• FDA Device Classification: Class 3 Medical Device

Device Problems
Failure To Calibrate	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 21:14:58