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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: CO2 Fractional Laser System, Lipo Laser System, Light Based Over The Counter Wrinkle Reduction,; Gynecological Therapy Device for Vaginal Health, PDT Photon skin rejuvenation,; Infrared Light Skin Care Device, Blue Light Skin Care Device, Laser Hair Growth Devices, LED Light Beauty Device,; Laser high blood sugar assisted treatment watch, Diabetes assisted treatment device, Large laser therapy machine,; Laser Pain Healing Machine, Laser Prostate Treatment Belt,Prostate cold laser red light therapy instrument,; Laser Pain Relief Belt, Multi-Spectrum handheld pain relief device,; LED Face Mask,Red Infrared Light Therapy Gloves,; LED Light Skin Rejuvenation Device, Low Energy Laser Health Support Device,; LED Red Light Therapy for Feet & Body, Skin Health UV Lamp ,UVB Light Therapy, 308nm Phototherapy Device,; Multi Spectrum Health Instrument, LED Gynecological Therapy Device for Vaginal Health, Vaginal laser rejuvenation stick,; Nail fungus treatment instrument, LED Breast Enhancement Device, Red light breast therapy device,; Over-The-Counter Powered Light Based Laser For Acne, Eye physiotherapy instrument, Four-color laser therapy watch,; PDT Skin Care Device, Red Light & Near Infrared Light Therapy Devices, Red Light Cap,; Physical cervical therapy device, Red and Blue Light Therapy.; Red and Blue Light Therapy, Laser nasal therapy device, Laser physical therapy instrument,; Red Light Beauty Device,Light therapy skincare device,; Red Light Therapy Ankle Joint Wrap, Red Light Therapy Belt forNeck, Chin,Shoulder,Back,Knee,Arm,; Red Light Therapy Feet Pad,Red Light Therapy seat Pad,Red Light Therapy Back Pad,; Red Light Therapy Panel, LED Light Therapy Torch, Light therapy instrument, LED Light Therapy Device,; Semiconductor Laser Treatment Instrument,Face Mask Light Therapy,Infrared light beauty rejuvenation device,; Wrist,Leg,Waist and Belly,Red Light Therapy Mat,
Classification Name: LAMP, INFRARED, THERAPEUTIC HEATING
Product Code: ILY
Device Class: 2
Regulation Number: 890.5500
Medical Specialty: Physical Medicine
Registered Establishment Name: Ziree (Shenzhen) Medical Technology Co.,Ltd
Registered Establishment Number: 3031191551
Owner/Operator: Ziree (shenzhen) Medical technology Co.,Ltd.
Owner/Operator Number: 10090456
Establishment Operations: Manufacturer
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