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 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 TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the next level by helping to reduce tension, relax facial muscles, and achieve healthier-looking skin by gently stimulating the face. It includes microcurrent, blue, red, and red+infrared light LED, and cleansing treatments, allowing you to customize your facial therapy in one easy-to-use versatile device. Use the variety of treatment rings to help lift, tone, rejuvenate, and deep clean.
Therabody, Inc.
TheraFace PRO Black
In Commercial Distribution

  • 00810036056724 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
The TheraFace PRO is a 4-in-1 handheld device that takes facial wellness to the next level by helping to reduce tension, relax facial muscles, and achieve healthier-looking skin by gently stimulating the face. It includes microcurrent, blue, red, and red+infrared light LED, and cleansing treatments, allowing you to customize your facial therapy in one easy-to-use versatile device. Use the variety of treatment rings to help lift, tone, rejuvenate, and deep clean.
Therabody, Inc.
TheraFace PRO White
In Commercial Distribution

  • 00810036056687 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-812W
Not in Commercial Distribution

  • 06976415770187 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-812B
Not in Commercial Distribution

  • 06976415770170 ()


  • Transcutaneous electrical stimulation probe
  • Blue/red/infrared phototherapy lamp
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-810W
Not in Commercial Distribution

  • 06976415770163 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
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