Product Classification

• Device: microscope, specular
• Regulation Description: AC-powered slitlamp biomicroscope.
• Definition: Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: NQE
• Premarket Review: Ophthalmic Devices (DHT1A); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.1850
• 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

• 10-117 ANSI Z80.37-2017 (R2021)
  American National Standard for Ophthalmics - Slit-Lamp Microscopes
• 10-122 ISO 10939 Third edition 2017-05
  Ophthalmic instruments - Slit-lamp microscopes
• 10-130 ANSI Z80.36-2021
  American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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