Laser For Gastro-urology Use

Device Code: 2171

Product Code(s): LNK

Device Classification Information

• Device Type ID: 2171
• Device Name: Laser For Gastro-urology Use
• Regulation Description: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.
• Regulation Medical Specialty: General & Plastic Surgery
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(k)
• CFR Regulation Number: 878.4810 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LNK
• 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: 2171
• Device: Laser For Gastro-urology Use
• Product Code: LNK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.
• CFR Regulation Number: 878.4810 [🔎]

TPLC Last Update: 2019-04-02 20:07:05