Product Classification

• Device: laser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
• Review Panel: Ophthalmic
• Product Code: LOI
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 10-66 ISO 10936-2 Second edition 2010-01-15
  Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
• 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)]
• 12-356 IEC 60601-2-22 Edition 4.0 2019-11
  Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Third Party Review

Not Third Party Eligible