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Optatint, Inc.

United StatesFDA applicant, unverified

Devices
2

What Optatint, Inc. makes

Optatint, Inc. manufactures UVASORB-400, a specialized intraocular lens material designed to filter ultraviolet light, and RHODA-LUX lens blanks, which serve as base components for intraocular lenses used in cataract surgery. These products are intended for implantation in the eye to replace the natural lens and provide optical correction while reducing exposure to harmful ultraviolet radiation.

The company’s portfolio is regulated under Class II (U) devices in the United States, with relevant products listed via the FDA’s 510(k) premarket notification process. These devices are tracked in regulatory registries under the FDA’s jurisdiction, ensuring compliance with medical device standards for intraocular implants.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Uvasorb-400 Ref K854442

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Rhoda-Lux Lens Blanks Ref K850909

    Active Regimes: 510(k) Registry: 510(k) Class:—

Frequently asked questions

How many devices does Optatint, Inc. have in the registry?

The registry currently lists 2 devices for Optatint, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Optatint, Inc.'s devices?

Among its 2 most recently registered devices, Optatint, Inc. has devices listed in FDA 510(k) (2 devices).

What are the newest devices from Optatint, Inc. in the registry?

The most recently registered devices listed for Optatint, Inc. include UVASORB-400 and RHODA-LUX LENS BLANKS.

Generated automatically from registry data and not verified by a human reviewer.