Identifiers
- 510(k) Number
- K993487 FDA 510(k)
- FDA Product Code
- LRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5928 FDA 510(k)
- Regulation Number
- 886.5928 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Paragon Lens Vial is a contact lens case designed for the storage and maintenance of contact lenses. It consists of a vial body, a cap, and an optional gasket or claw assembly to secure the lens.
The device is available in various configurations, including different cap colors and claw sizes to accommodate specific lens requirements. This product is regulated as a Class 2 ophthalmic device and has received FDA 510(k) clearance.
Frequently asked questions
What is the primary purpose of the Paragon Lens Vial?
The Paragon Lens Vial is designed specifically for the storage and maintenance of contact lenses. It provides a secure environment for the lenses when they are not being worn.
What components are included with the Paragon Lens Vial?
The device consists of a vial body and a cap. It also includes an optional gasket or claw assembly, which is used to help secure the contact lens within the vial.
Are there different options available for this lens case?
Yes, the Paragon Lens Vial is available in various configurations. These include different cap colors and claw sizes, which allow the case to accommodate specific lens requirements.
What is the regulatory status of the Paragon Lens Vial?
The Paragon Lens Vial is regulated as a Class 2 ophthalmic device and has received FDA 510(k) clearance under the number K993487.
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: Paragon Vision Sciences, Fitting Guides & Package Inserts | Paragon Vision Sciences, Paragon Vision Sciences, Inc. 900 Vial Assembly - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993487 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon Vision Sciences
Sources (1)
- FDA 510(k) K993487 24 fields · synced Sep 21, 2026