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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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Shani Darden Branded Facemask Blue, Red & NIR facemask
I-SMART DEVELOPMENTS LIMITED
TN2118
In Commercial Distribution

  • 05060534510517 ()
115-HGSD

  • Blue/red/infrared phototherapy lamp
MZ Skin Mask: MZ Skin LightMAX Supercharged LED Mask 2.0
I-SMART DEVELOPMENTS LIMITED
TN2025
In Commercial Distribution

  • 05060534510418 ()
140-MZ

  • Blue/red/infrared phototherapy lamp
EOS X by Deesse Pro Blue, Red, Green & NIR facemask indicated for Acne and Wrinkles.
I-SMART DEVELOPMENTS LIMITED
TN2214
In Commercial Distribution

  • 05060534510401 ()


  • 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
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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