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Neolens, Inc.

United StatesFDA applicant, unverified

Devices
2

What Neolens, Inc. makes

Neolens, Inc. manufactures prescription spectacle lenses and sunglasses designed for corrective and protective eyewear. These products are intended for general use in vision correction and UV protection.

The company’s portfolio is classified under FDA’s Class I medical devices, requiring 510(k) clearance for market authorisation. The devices are listed in the FDA’s 510(k) registry, and the company is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Neolens Prescription Spectacle Lens Ref K882814

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Neolens Sunglasses Ref K882813

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

Frequently asked questions

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

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

Which registries list Neolens, Inc.'s devices?

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

What risk classes do Neolens, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Neolens, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Neolens, Inc. include NEOLENS PRESCRIPTION SPECTACLE LENS and NEOLENS SUNGLASSES.

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