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Endymion Medical, Ltd.

IsraelFDA applicant, unverified

Devices
2

What Endymion Medical, Ltd. makes

Endymion Medical, Ltd. manufactures non-invasive skin therapy systems, including the IMAGINE TC SKIN THERAPY SYSTEM and the NEWA SKIN THERAPY SYSTEM, designed for aesthetic and therapeutic skin treatments. These devices are intended for procedures such as skin rejuvenation, pigmentation reduction, and hair removal.

The company’s portfolio is regulated under Class II medical devices in the US, with devices listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Imagine Tc Skin Therapy System Ref K083461

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Newa Skin Therapy System Ref K130793

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

Frequently asked questions

How many devices does Endymion Medical, Ltd. have in the registry?

The registry currently lists 2 devices for Endymion Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Endymion Medical, Ltd.'s devices?

Among its 2 most recently registered devices, Endymion Medical, Ltd. has devices listed in FDA 510(k) (2 devices).

What risk classes do Endymion Medical, Ltd.'s devices fall under?

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

What are the newest devices from Endymion Medical, Ltd. in the registry?

The most recently registered devices listed for Endymion Medical, Ltd. include IMAGINE TC SKIN THERAPY SYSTEM and NEWA SKIN THERAPY SYSTEM.

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