Product Classification

• Device: instrument, vitreous aspiration and cutting, ac-powered
• Regulation Description: Vitreous aspiration and cutting instrument.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: HQE
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.4150
• 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

• 10-65 ISO 15752 Second edition 2010-01-15
  Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
• 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
• 10-126 IEC 80601-2-58 Edition 2.0 2014-09
  Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery [Including AMENDMENT 1 (2016)]
• 10-136 IEC 80601-2-58 Edition 3.0 2024-03
  Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

Guidance Document

• Third Party Review Guidance for Vitreous Aspiration and Cutting Device Premarket Notification (510(k))

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