FDA device listing

LED Therapy Mat, Red light therapy wand, Red light cap, Red light therapy helmet,Sauna infrared lamp (T50D3-L70), Sauna…

FDA device listing 1455410017 · Shenzhen Andy Photoelectric Technology Co., Ltd.

Key facts

Proprietary names LED Therapy Mat, Red light therapy wand, Red light cap, Red light therapy helmet,Sauna infrared lamp (T50D3-L70), Sauna lamp (T50D3-LT),Therapy lamp, Led light therapy, Red light therapy, Red light therapy belt, Facial LED device, LED Facial Mask,
Owner/operator Shenzhen Andy Photoelectric Technology Co., Ltd.
Owner/operator number 10094322
Product codes ILY
Device names ILY - Lamp, Infrared, Therapeutic Heating
Device class Class II
Classification regulations (21 CFR) 890.5500
Review panels Physical Medicine
Registered establishments SHENZHEN ANDY PHOTOELECTRIC TECHNOLOGY CO., LTD.
Establishment registrations 3042277467
FEI numbers 3042277467
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer
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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