Identity
- Trade Name
- ELASTIC UVA PC IOL. FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P880091 FDA PMA
- FDA Product Code
- HQL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.3600 FDA PMA
- Regulation Number
- 886.3600 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Elastic UVA PC IOL is an intraocular lens designed for implantation within the eye to replace the natural lens following cataract surgery or other conditions requiring lens removal. It is a foldable, acrylic intraocular lens with a specific optical design intended to restore clear vision by focusing light onto the retina.
This device is supplied sterile and intended for single-use. It is classified as a Class III medical device under FDA regulations and has received FDA_PMA authorization. The lens is available in various optical powers and is intended for use in standard ophthalmic surgical settings, adhering to standard sterility and handling protocols for intraocular implants.
Frequently asked questions
What is the Elastic UVA PC IOL used for?
The Elastic UVA PC IOL is an intraocular lens designed for implantation within the eye to replace the natural lens following cataract surgery or other conditions requiring lens removal. It helps restore clear vision by focusing light onto the retina.
How is the Elastic UVA PC IOL supplied?
The device is supplied sterile and is intended for single-use only. It should be handled according to standard sterility protocols for intraocular implants during ophthalmic surgical procedures.
What sizes and models of the Elastic UVA PC IOL are available?
The lens is available in various optical powers to accommodate different patient needs. The specific sizes and models available would be determined by the manufacturer based on clinical requirements.
What is the regulatory status of the Elastic UVA PC IOL?
The Elastic UVA PC IOL has received FDA_PMA authorization and is classified as a Class III medical device under FDA regulations. It has been approved for use in standard ophthalmic surgical settings.
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 | P880091 | Class III | Active |
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Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (1)
- FDA PMA P880091 24 fields · synced Sep 18, 2026