Product Classification

• Device: endoilluminator
• Regulation Description: Endoscope and accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Ophthalmic
• Product Code: MPA
• Submission Type: 510(k)
• Regulation Number: 876.1500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 15004-2 First edition 2007-02-15 Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection
• ISO 15752 Second edition 2010-01-15 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test for optical radiation safety
• ISO 15004-1 First edition 2006-06-01 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

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