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Sdjmastervision (Fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241398

by Tianjin Mastervision Technology Co., Ltd.

Identifiers

510(k) Number
K241398 FDA 510(k)
FDA Product Code
HQD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5916 FDA 510(k)
Regulation Number
886.5916 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sdjmastervision (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are ophthalmic devices manufactured from machine latheable rigid gas permeable materials. These lenses are composed of siloxanyl fluoromethacrylate copolymers and are available in tinted versions with or without an ultraviolet light absorber.

This device is regulated under FDA 510(k) clearance K241398. It is classified as a contact lens for daily wear under regulation number 886.5916.

Frequently asked questions

What material is used to manufacture these contact lenses?

The SDJMASTERVISION lenses are manufactured from siloxanyl fluoromethacrylate copolymers. This material is a rigid gas permeable substance that is processed using machine latheable techniques to create the final ophthalmic device.

Are these lenses available with specific optical features?

Yes, these lenses are available in tinted versions. Additionally, they can be provided with or without an ultraviolet light absorber depending on the specific requirements of the wearer.

What is the intended wear schedule for this device?

These lenses are classified as contact lenses for daily wear under regulation number 886.5916. They are not intended for extended or overnight use.

What is the regulatory status of the SDJMASTERVISION lenses?

This device is regulated under FDA 510(k) clearance number K241398. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the ophthalmic specialty.

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: SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses ..., PDF Tianjin MasterVision Technology Co., Ltd. ℅ Bret Andre, K241398 - SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Pe..., SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tianjin Mastervision Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K241398 24 fields · synced Sep 21, 2026