FDA device listing

LUCION; VIMPLANT

FDA device listing 1631435620 · Cybermed Inc.

Key facts

Proprietary names LUCION; VIMPLANT
Owner/operator Cybermed Inc.
Owner/operator number 9048516
Premarket submissions K050033
Product codes LLZ
Device names LLZ - System, Image Processing, Radiological
Device class Class II
Classification regulations (21 CFR) 892.2050
Review panels Radiology
Registered establishments Cybermed Inc.
Establishment registrations 3003781339
FEI numbers 3003781339
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings