Product Classification

• Device: folders and injectors, intraocular lens (iol)
• Regulation Description: Intraocular lens guide.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: MSS
• Submission Type: 510(k)
• Regulation Number: 886.4300
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 11979-3 Second edition 2006-05-01 Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• tuv sud america inc.
• underwriters laboratories, inc.