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U.S. Department of Health and Human Services

Product Classification
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Device refractive corneal implant
Definition Intended for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure may be potentially deferred.
Physical State Two clear polymethylmethacrylate segments, each having an arc length of 150 degree.
Technical Method When placed in the corneal stroma outside of the patient's central optical zone, the product reduces the cone by flattening the cornea and for non-central keratoconus repositions the cone centrally.
Target Area Corneal stroma
Review Panel Ophthalmic
Product CodeODK
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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