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510(k) Data Aggregation
K Number
K032104Device Name
AMNIOLENS
Manufacturer
BIO-TISSUE, INC.
Date Cleared
2003-12-12
(157 days)
Product Code
NQB
Regulation Number
886.3130Why did this record match?
Applicant Name (Manufacturer) :
BIO-TISSUE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.
The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure or adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.
Device Description
The ProKera™ is a corneal-epithelial insert, consisting of an ophthalmic conformer that incorporates amniotic membrane. The device is intended for use in eyes in which the ocular surface cells have been damaged, or underlying stroma is inflamed and scarred.
The device is inserted between the eyeball and the eyelid to maintain space in the orbital cavity and to prevent closure on adhesions. Insertion of the conformer also enables application of the amniotic membrane to the ocular surface without the need for sutures.
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