BD 1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID FDA PMA
- Generic Name
- AID, SURGICAL, VISCOELASTIC FDA PMA
Identifiers
- PMA Number
- P960011 FDA PMA
- FDA Product Code
- LZP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.4275 FDA PMA
- Regulation Number
- 886.4275 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
This device is a Surgical Aid, Viscoelastic (FDA classification III) designed to protect the corneal endothelium during ophthalmic procedures. It is formulated as a 1% sodium hyaluronate solution, providing viscoelastic properties to maintain anterior chamber depth and reduce trauma during cataract extraction, intraocular lens implantation, and anterior segment surgery.
The fluid is supplied sterile and intended for single-use in controlled surgical environments. It is non-magnetic and MRI-safe, with no reported restrictions for use in magnetic resonance imaging settings. Available in standard ophthalmic packaging, it requires refrigeration prior to use and must be discarded after opening. Authorised under FDA PMA (P960011), it adheres to regulatory standards for ophthalmic viscoelastic devices.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P960011 | Class III | Active |
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Manufacturer
- Manufacturer
- Altacor , Ltd.
Sources (1)
- FDA PMA P960011 24 fields · synced Oct 6, 2026