FDA device listing

Ion beauty device

FDA device listing 1285740503 · Brain Health Spectrum (Chengdu) Artificial Intelligence Tech

Key facts

Proprietary names Ion beauty device
Owner/operator Brain Health Spectrum (Chengdu) Artificial Intelligence Tech
Owner/operator number 10095091
Product codes FLG
Device names FLG - Cleaner, Ultrasonic, Medical Instrument
Device class Class I
Classification regulations (21 CFR) 880.6150
Review panels General Hospital
Registered establishments BRAIN HEALTH SPECTRUM (CHENGDU) ARTIFICIAL INTELLIGENCE TECHNOLOGY CO., LTD.
Establishment registrations 3043709874
FEI numbers 3043709874
Establishment operations Foreign Exporter, Manufacturer, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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

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