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Axiom Usa., Inc.

United StatesFDA 510(k) applicant, unverified

Devices
4

What Axiom Usa., Inc. makes

Axiom Usa., Inc. makes low-level laser therapy (LLLT) devices, such as the AXIOM BIOLASER LLLT SERIES-1 and SERIES-3, as well as devices like the DRX5000 and DRX3000.

The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry, with the company based in the US.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Axiom Biolaser Lllt Series-1 Ref K030622

    Class II
    Active 510(k) 510(k) II
  • Axiom Biolaser Lllt Series-3 Ref K033015

    Class II
    Active 510(k) 510(k) II
  • DRX5000 Ref K023160

    Class II
    Active 510(k) 510(k) II
  • DRX3000 Ref K022602

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

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

The registry currently lists 4 devices for Axiom Usa., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Axiom Usa., Inc.'s devices?

Among its 4 most recently registered devices, Axiom Usa., Inc. has devices listed in FDA 510(k) (4 devices).

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

Among its 4 most recently registered devices, the classes recorded for Axiom Usa., Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Axiom Usa., Inc. include AXIOM BIOLASER LLLT SERIES-1, AXIOM BIOLASER LLLT SERIES-3, DRX5000 and DRX3000.

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