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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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The LED Eye Mask, model: EY-20N is an over-the-counter light-emiting diode (LEDdevice that emits energy for dermatology to treat wrinkles within the periorbital region. The device usesfour types of LEDs is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the mainunit, USB cable cord and velcro straps and removable eye protection. There is a total of 40 LEDs toprovide a power intensity of about 65 mW/cm?. The device has only one button to turn on/off.The user wears the device on their eye area for the treatment, and the device will shut down automatically
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-20N
In Commercial Distribution

  • 00810137610429 ()


  • Blue/red/infrared phototherapy lamp
The LED Eye Perfector (Model: EY-36B) is an Over-the-Counter (0TC) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-36B
In Commercial Distribution

  • 00695866567110 ()


  • Blue/red/infrared phototherapy lamp
EXCHANGER 61399400964 1EA HT BIOTHERM
MEDTRONIC, INC.
61399400964
In Commercial Distribution

  • 30613994009648 ()
  • 50613994009642 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
EXCHANGER 61399400870 1EA EMOTHRMII HT
MEDTRONIC, INC.
61399400870
In Commercial Distribution

  • 30613994008702 ()
  • 50613994008706 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
FAQ™ 200 Plus is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Black
In Commercial Distribution

  • 07640260120662 ()


  • Blue/red/infrared phototherapy lamp
4 mode full body panel
Biophotas, Inc.
Series 2 DELUX XL C/US
In Commercial Distribution

  • 00850523007938 ()
CXL2-001

  • Blue/red/infrared phototherapy lamp
4 mode full body panel
Biophotas, Inc.
Series 2 DELUX C/US
In Commercial Distribution

  • 00850523007891 ()
CDL2-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
Biophotas, Inc.
Series 2 SKIN C/US
In Commercial Distribution

  • 00850523007808 ()
CSK2-001

  • Blue/red/infrared phototherapy lamp
5 Mode Light therapy device with capability of 3 Panels connected
Biophotas, Inc.
Series 2 ELITE C/US
In Commercial Distribution

  • 00850523007761 ()
ELS2-002

  • Blue/red/infrared phototherapy lamp
2 mode small panel
Biophotas, Inc.
Series 2 FACE C/US
In Commercial Distribution

  • 00850523007754 ()
CLF2-001

  • Blue/red/infrared phototherapy lamp
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