FDA device listing

Cutera Excel V

FDA device listing 2049953057 · Laser Marketing Group, LLC

Key facts

Proprietary names Cutera Excel V
Owner/operator Laser Marketing Group, LLC
Owner/operator number 10041358
Premarket submissions K132185
Product codes GEX
Device names GEX - Powered Laser Surgical Instrument
Device class Class II
Classification regulations (21 CFR) 878.4810
Review panels General & Plastic Surgery
Registered establishments Laser Marketing Group, LLC
Establishment registrations 3009736547
FEI numbers 3009736547
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 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