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U.S. Department of Health and Human Services

Product Classification

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Device keratoprosthesis, temporary implant, surgical use
Regulation Description Keratoprosthesis.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeMLP
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type 510(k)
Regulation Number 886.3400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Guidance Document
Third Party Review
Accredited Persons
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