Product Classification

• Device: laser, ophthalmic
• Regulation Description: Ophthalmic laser.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: HQF
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.4390
• Device Class: 2
• 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
• 10-130 ANSI Z80.36-2021
  American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
• 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)]

Guidance Document

• Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc