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Lento Medical Innovation, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000028244 FEI 3014545280

Devices
2
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI

What Lento Medical Innovation, Inc. makes

Lento Medical Innovation produces the PtoleMedic System, a medical device designed for joint alignment procedures.

The PtoleMedic System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • PtoleMedic System Ref PMS-001

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • PtoleMedic System Ref K202521

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

Company details

EUDAMED SRN
US-MF-000028244
FDA FEI number
3014545280
EUDAMED status
Active
EUDAMED registered name
Lento Medical Innovation, Inc.
EUDAMED abbreviated name
Lento
Registered address
15110, Northwest Freeway, Suite 150, 77040, Houston, United States
Phone
+1 510 413 3230
PRRC contact
Alex Park(public in EUDAMED)

From the company website

Read 18 Oct 2026

With breakthroughs in the medical world occurring virtually every day, joint alignment is prime for game-changing advancements. Lento Medical Innovation offers leading-edge, science-driven solutions, presenting healthcare professional and patients with a paradigm shift in joint alignment methodology and technology.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Lento Medical Innovation, Inc. have in the registry?

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

Which registries list Lento Medical Innovation, Inc.'s devices?

Among its 2 most recently registered devices, Lento Medical Innovation, Inc. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Lento Medical Innovation, Inc.'s devices fall under?

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

What are the newest devices from Lento Medical Innovation, Inc. in the registry?

The most recently registered devices listed for Lento Medical Innovation, Inc. include PtoleMedic System.

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