Product Classification

• Device: keratoprosthesis, temporary implant, surgical use
• Regulation Description: Keratoprosthesis.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Product Code: MLP
• Submission Type: 510(k)
• Regulation Number: 886.3400
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance on 510(k) Submissions for Keratoprostheses, Final

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.