Identity
- Trade Name
- RESURE SEALANT FDA PMA
- Generic Name
- Ophthalmic Sealant FDA PMA
Identifiers
- PMA Number
- P130004 FDA PMA
- FDA Product Code
- PFZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
The ReSure Sealant is an ophthalmic sealant used for the intraoperative management of clear corneal incisions with a demonstrated wound leak, up to 3.5mm in size. It is designed to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (IOL) placement in adults. The device is intended to achieve a temporary dry surface on the wound. The ReSure Sealant is a Class 3 device, classified under the product code PFZ.
The ReSure Sealant is supplied by Ocular Therapeutix, Inc. and has received FDA PMA authorization, with the PMA number P130004. The device is indicated for use in ophthalmic procedures, specifically for the management of clear corneal incisions. The ReSure Sealant is approved for use in adults and is designed to be used in a clinical setting, such as a hospital or surgical center.
Frequently asked questions
What is the ReSure Sealant used for?
The ReSure Sealant is used for the intraoperative management of clear corneal incisions with a demonstrated wound leak, up to 3.5mm in size, following cataract surgery with intraocular lens (IOL) placement in adults.
What is the classification of the ReSure Sealant?
The ReSure Sealant is classified as a Class 3 device, under the product code PFZ.
What is the authorization status of the ReSure Sealant?
The ReSure Sealant has received FDA PMA authorization, with the PMA number P130004.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products | Innovative Eye Care Solutions by Ocular Therapeutix, FDA approves ReSure sealant, ReSure Sealant Instructional Video - Eyetube, ReSure Sealant - Beye, Premarket Approval (PMA) - FDA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P130004 | Class III | Active |
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Manufacturer
- Manufacturer
- Ocular Therapeutix, Inc.
Sources (1)
- FDA PMA P130004 24 fields · synced Sep 18, 2026