FDA device listing

Picasso Pro Diode Laser

FDA device listing 1648168058 · CAO Group, Inc.

Key facts

Proprietary names Picasso Pro Diode Laser
Owner/operator CAO Group, Inc.
Owner/operator number 9043755
Premarket submissions K254197
Product codes EEG, GEX, NVK
Device names EEG - Heat Source For Bleaching Teeth, GEX - Powered Laser Surgical Instrument, NVK - Laser, Dental, Soft Tissue
Device class Class I, Class II
Classification regulations (21 CFR) 872.6475, 878.4810
Review panels Dental, General & Plastic Surgery
Registered establishments CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED, CAO GROUP, INC.
Establishment registrations 1725006, 3004475754
FEI numbers 3003258642, 3004475754
Establishment operations Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 10–99 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