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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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C-Wave LED Mask for Neck & Décolleté Beauty Pie- Rebranded Variant of TN2037 (LED Neck & Dec Device)
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510999 ()


  • Red/infrared light phototherapy unit
Priori UnveiLED Glove
I-SMART DEVELOPMENTS LIMITED
TN19S
In Commercial Distribution

  • 05060534510593 ()
125A

  • Red/infrared light phototherapy unit
Priori UnveiLED Neck & Decollete
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510586 ()
112A

  • Red/infrared light phototherapy unit
Boost LED Collar- The Light Salon
I-SMART DEVELOPMENTS LIMITED
TN2113
In Commercial Distribution

  • 05060534510494 ()
150-LS

  • Red/infrared light phototherapy unit
Décolletage & Neck Device- Boost Branded (The Light Salon)- Black Controller
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510388 ()
112A

  • Cosmetic red-light phototherapy system, home-use
LED Body Panel- Boost Branded- (The Light Salon)- Black Controller
I-SMART DEVELOPMENTS LIMITED
TN19I
In Commercial Distribution

  • 05060534510364 ()
145A

  • Cosmetic red-light phototherapy system, home-use
Glove Device- Currentbody Branded
I-SMART DEVELOPMENTS LIMITED
TN19S
Not in Commercial Distribution

  • 05060534510340 ()


  • Cosmetic red-light phototherapy system, home-use
LED glove device- handLITE branded
I-SMART DEVELOPMENTS LIMITED
TN19S
In Commercial Distribution

  • 05060534510241 ()
125A

  • Red/infrared light phototherapy unit
LED Glove Device- DP Dermaceuticals Branded
I-SMART DEVELOPMENTS LIMITED
TN19S
In Commercial Distribution

  • 05060534510227 ()
125A

  • Cosmetic red-light phototherapy system, home-use
LED Glove Device- Omnilux Contour Branded
I-SMART DEVELOPMENTS LIMITED
TN19S
In Commercial Distribution

  • 05060534510210 ()
125A

  • Red/infrared light phototherapy unit
LED Décolletage & Neck Device-Opatra Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510203 ()
112A

  • Cosmetic red-light phototherapy system, home-use
Décolletage & Neck Device- Currentbody Skin Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
Not in Commercial Distribution

  • 05060534510142 ()
112A

  • Cosmetic red-light phototherapy system, home-use
LED Neck & Décolletage Device- Omnilux Contour Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510135 ()
112A

  • Cosmetic red-light phototherapy system, home-use
LED Décolletage & Neck Device- DP Dermaceuticals Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510111 ()
112A

  • Cosmetic red-light phototherapy system, home-use
Décolletage & Neck Device- decoLITE Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510036 ()
112A

  • Cosmetic red-light phototherapy system, home-use
KINEON MOVE+, model: XG-01B, is an over-the-counter light-emitting diode (LED) combined laser-emitting device that emits energy for knee pain relief.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
XG-01B
In Commercial Distribution

  • 05060981240005 ()


  • Red-light phototherapy unit, professional
S2194 LED Helmet PRX
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130596 ()


  • Red-light phototherapy unit, professional
S2185 LED Helmet
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130589 ()


  • Red-light phototherapy unit, professional
S2197 LED Lollipop
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130572 ()


  • Red-light phototherapy unit, professional
S2196 PRX Lollipop Probe
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130565 ()


  • Red-light phototherapy unit, professional
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