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Isotech Corp.

United StatesFDA applicant, unverified

Devices
2

What Isotech Corp. makes

Isotech Corp. manufactures the EYSOTEK, a medical device designed for ocular imaging and diagnostic purposes, specifically targeting retinal and anterior segment analysis.

The EYSOTEK is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. 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

  • Eysotek Ref K932132

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eysotek Ref K932133

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

Frequently asked questions

How many devices does Isotech Corp. have in the registry?

The registry currently lists 2 devices for Isotech Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Isotech Corp.'s devices?

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

What risk classes do Isotech Corp.'s devices fall under?

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

What are the newest devices from Isotech Corp. in the registry?

The most recently registered devices listed for Isotech Corp. include EYSOTEK.

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