Product Classification

• Device: ophthalmoscope, laser, scanning
• Regulation Description: Ophthalmoscope.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: MYC
• Premarket Review: Ophthalmic Devices (DHT1A); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.1570
• 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

• 10-70 ISO 10943 Third edition 2011-08-15
  Ophthalmic instruments - Indirect ophthalmoscopes
• 10-123 ISO 15004-1 Second edition 2020-5
  Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
• 10-130 ANSI Z80.36-2021
  American National Standard for Ophthalmics - Light Hazard Protection for Ophthalmic Instruments
• 10-132 ISO 10942 Third edition 2022-01
  Ophthalmic instruments - Direct ophthalmoscopes
• 12-349 NEMA PS 3.1 - 3.20 2022d
  Digital Imaging and Communications in Medicine (DICOM) Set
• 12-352 NEMA PS 3.1 - 3.20 2023e
  Digital Imaging and Communications in Medicine (DICOM) Set

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