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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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FAQ™ 201 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Pink Ruby
In Commercial Distribution

  • 07640260120167 ()


  • Blue/red/infrared phototherapy lamp
Plasma Thawer
Cardinal Health 200, LLC
CH-PT1000
In Commercial Distribution

  • 50885380024847 ()
CH-PT1000

  • Cryopreserved blood/tissue thawing unit
No Description
ICU MEDICAL, INC.
80-01-040
In Commercial Distribution

  • 50695085804008 ()


  • Heater/cooler system tester kit
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
The LUSTRE 3XPREsS Light Beauty Therapy patches (Model: PR500l) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
PR5001
In Commercial Distribution

  • 05060282690318 ()


  • Blue/red/infrared phototherapy lamp
The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
PR6001
In Commercial Distribution

  • 05060282690301 ()


  • Blue/red/infrared phototherapy lamp
The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK-04
In Commercial Distribution

  • 00856957008022 ()


  • Blue/red/infrared phototherapy lamp
The HlGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK66-L
In Commercial Distribution

  • 00850049532471 ()


  • Blue/red/infrared phototherapy lamp
The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
61043
In Commercial Distribution

  • 00810137610436 ()


  • Blue/red/infrared phototherapy lamp
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