FDA device listing

7 color LED Facial Mask, model:MJ01,MJ02,MJ03,MJ04,MJ05,MJ06,MJ07,MJ08.MJO9.MJ10,MJ11,MJ12,MJ13,MJ14.MJ15.MJ16,7 color…

FDA device listing 1333274817 · ONLYCARE INC

Key facts

Proprietary names 7 color LED Facial Mask, model:MJ01,MJ02,MJ03,MJ04,MJ05,MJ06,MJ07,MJ08.MJO9.MJ10,MJ11,MJ12,MJ13,MJ14.MJ15.MJ16,7 color LED Facial Mask plastic, model: RV20221MJ, RV20222A, RV20223B, RV20224C, RV20225D;,7 color LED Facial Mask silicone, model: RV20233RGB;,7 color LED Facial Mask silicone with neck, model: RV20232RGB;,7 color LED neck Mask silicone, model: RV20331RGB;,Handheld Red Light Therapy…
Owner/operator ONLYCARE INC
Owner/operator number 10092480
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 ONLYCARE INC
Establishment registrations 3035374295
FEI numbers 3035374295
Establishment operations 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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