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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Kingdo LED Light Therapy Mask (BLACK)
Guangdong Newdermo Biotech Co.,Ltd.
FM-02
In Commercial Distribution

  • 16974020960976 ()
  • 06974020960979 ()


  • Blue/red/infrared phototherapy lamp
Kingdo LED Light Therapy Mask white
Guangdong Newdermo Biotech Co.,Ltd.
FM-02
In Commercial Distribution

  • 16974020960969 ()
  • 06974020960962 ()


  • Blue/red/infrared phototherapy lamp
AURA Plus LED Light Therapy Mask
Guangdong Newdermo Biotech Co.,Ltd.
FM-02
In Commercial Distribution

  • 06974020960955 ()
  • 16974020960952 ()


  • Blue/red/infrared phototherapy lamp
VOGUENOW LUMINX LED LIGHT THERAPY MASK
Guangdong Newdermo Biotech Co.,Ltd.
FM-02
In Commercial Distribution

  • 06974020960948 ()
  • 16974020960945 ()


  • Blue/red/infrared phototherapy lamp
LED light therapy mask
Guangdong Newdermo Biotech Co.,Ltd.
FM-01
In Commercial Distribution

  • 16974020960914 ()
  • 06974020960917 ()


  • Blue/red/infrared phototherapy lamp
Cooling Box
MDHC Life Technologies (Kunshan) Co., LTD.
5 pcs/bag
In Commercial Distribution

  • 06974669350322 ()


  • Heater/cooler system tester kit
No Description
Ningbo Hesi Electronics Co., Ltd.
HK209
In Commercial Distribution

  • 06974746830013 ()


  • Blue/red/infrared phototherapy lamp
No Description
Ningbo Hesi Electronics Co., Ltd.
HK207
In Commercial Distribution

  • 06974746830006 ()


  • Blue/red/infrared phototherapy lamp
No Description
Hunan Guangye Biotechnology Co., Ltd.
KFB265
In Commercial Distribution

  • 06975587680010 ()


  • Blue/red/infrared phototherapy lamp
Performa Adjustable Paraffin Bath
Performance Health Supply, LLC
081706738
In Commercial Distribution

  • 00885914070932 ()


  • Physical therapy paraffin wax bath
LED Light Therapy Mask
SILKN BEAUTY LTD
FM-03
In Commercial Distribution

  • 27290019840057 ()
  • 17290019840050 ()
  • 07290019840053 ()
7290019840053

  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne
Shenzhen Rainbow Technology Co.,Ltd
RB-081
In Commercial Distribution

  • 06978368600818 ()
  • 16978368600815 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-030
In Commercial Distribution

  • 06978368600306 ()
  • 16978368600303 ()


  • Blue/red/infrared phototherapy lamp
Red+Infrared light:Treatment of full-face wrinkles. Red light:Treatment of full-face wrinkles. Blue light:Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-008
In Commercial Distribution

  • 16978368600082 ()
  • 06978368600085 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-008
In Commercial Distribution

  • 06978368600054 ()
  • 16978368600051 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008JB
In Commercial Distribution

  • 06978368600047 ()
  • 16978368600044 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008J
In Commercial Distribution

  • 06978368600030 ()
  • 16978368600037 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008GB
In Commercial Distribution

  • 06978368600023 ()
  • 16978368600020 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008G
In Commercial Distribution

  • 06978368600016 ()
  • 16978368600013 ()


  • Blue/red/infrared phototherapy lamp
Led Mask/CD07S
Shenzhen Wells Optoelectronics Co.,Ltd.
CD07S
In Commercial Distribution

  • 16977182810073 ()


  • Blue/red/infrared phototherapy lamp
LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are available individually on treatment heads or a mix of wavelengths on the same treatment head. There is a Touch Screen Display for entering treatment times and selecting treatment heads. The unit is mounted on a base with casters for moving around a clinic.
Medtek Lighting Corporation
7000A
In Commercial Distribution

  • B3437000A1 ()

  • Area/Surface Area: 800 Square centimeter
  • Weight: 60 Pound


  • Blue/red/infrared phototherapy lamp
Mi is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a non. invasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment offull-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for thepurpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness.minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporaryrelaxation of muscles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
TY-01
In Commercial Distribution

  • 06970006971212 ()


  • Blue/red/infrared phototherapy lamp
The LED Eve Mask (Model: EY-20R) is an Over-the-Counter (OTc) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-20R
In Commercial Distribution

  • 06970006971144 ()


  • Blue/red/infrared phototherapy lamp
(30) Per Case -Infrared Massager Heating Device with Auto Shut-Off - Light Bulb is Included
PRO MEDICAL SUPPLIES, INC.
PM-750
In Commercial Distribution

  • 10185098000853 ()
  • 18509800085330 ()
PM-750

  • Hand-held electric massager
Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)
DiaDent Group International
DUO-PEN HEATING CONDENSOR(08-55)
In Commercial Distribution

  • 08806383557023 ()
4007-2074

  • Endodontic obturation system
Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)
DiaDent Group International
DUO-PEN HEATING CONDENSOR(06-50)
In Commercial Distribution

  • 08806383557016 ()
4007-2073

  • Endodontic obturation system
Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)
DiaDent Group International
DUO-PEN HEATING CONDENSOR(04-50)
In Commercial Distribution

  • 08806383557009 ()
4007-2072

  • Endodontic obturation system
Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)
DiaDent Group International
DUO-PEN HEATING CONDENSOR(04-45)
In Commercial Distribution

  • 08806383556996 ()
4007-2071

  • Endodontic obturation system
Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.)
DiaDent Group International
DUO-PEN HEATING CONDENSOR(04-40)
In Commercial Distribution

  • 08806383556989 ()
4007-2070

  • Endodontic obturation system
EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
DiaDent Group International
HEATING CONDENSER (#XF /ML)
In Commercial Distribution

  • 08806383554916 ()
4005-2076

  • Endodontic obturation system
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