Product Classification

• Device: folders and injectors, intraocular lens (iol)
• Regulation Description: Intraocular lens guide.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: MSS
• Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Ophthalmic Devices (DHT1A)
• Submission Type: 510(k)
• Regulation Number: 886.4300
• Device Class: 1
• 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 Standard

• 10-78 ISO 11979-3 Third edition 2012-12-01
  Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods

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
• sgs north america
• third party review group, llc