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U.S. Department of Health and Human Services

Product Classification
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Device ophthalmic sealant
Definition An ophthalmic sealant is intended to maintain an incision closure and aid in preventing fluid egress from incisions in the eye.
Physical State A topical liquid/hydrogel/material which creates a temporary adherent closure.
Technical Method An ophthalmic sealant device is applied to an incision in the eye following an intraocular surgery. Once applied to the surface of the eye, the device adheres to the ocular tissue and aids in incision closure and prevention of fluid egress.
Target Area eye
Review Panel Ophthalmic
Product CodePFZ
Premarket Review Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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