Product Classification

• Device: camera, ophthalmic, ac-powered
• Regulation Description: Opthalmic camera.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: HKI
• Submission Type: 510(k)
• Regulation Number: 886.1120
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 15004-1 First edition 2006-06-01 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments
• ISO 15004-2 First edition 2007-02-15 Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection
• ISO 10940 Second edition 2009-08-01 Ophthalmic instruments - Fundus Cameras

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• tuv sud america inc.
• underwriters laboratories, inc.