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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This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED-Pro Mini
In Commercial Distribution

  • 08809922440053 ()


  • Red/infrared light phototherapy unit
This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red) and 850nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED
In Commercial Distribution

  • 08809922440046 ()


  • Red/infrared light phototherapy unit
This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED-Pro
In Commercial Distribution

  • 08809922440039 ()


  • Red/infrared light phototherapy unit
No Description
MASIMO CORPORATION
9900
In Commercial Distribution

  • 00843997009379 ()
  • 00843997005111 ()


  • Pulse oximeter
No Description
MASIMO CORPORATION
9800
In Commercial Distribution

  • 00843997009362 ()


  • Pulse oximeter
No Description
MASIMO CORPORATION
9700
In Commercial Distribution

  • 00843997009355 ()


  • Pulse oximeter
No Description
MASIMO CORPORATION
9574
In Commercial Distribution

  • 00843997008310 ()


  • Patient monitoring system module, pulse oximetry
No Description
MASIMO CORPORATION
9573
In Commercial Distribution

  • 00843997008303 ()


  • Patient monitoring system module, pulse oximetry
Beauty Pie C -WAVE REJUVENATING LED TREATMENT FOR HANDS Brand Variant of the LED Glove (TN19S)
I-SMART DEVELOPMENTS LIMITED
TN19S
In Commercial Distribution

  • 05060534511071 ()
125A

  • Red/infrared light phototherapy unit
C-Wave LED Mask for Neck & DƩcolletƩ 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
DƩcolletage & 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 DƩcolletage & Neck Device-Opatra Branded
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510203 ()
112A

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

  • 05060534510135 ()
112A

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

  • 05060534510111 ()
112A

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

  • 05060534510036 ()
112A

  • Cosmetic red-light phototherapy system, home-use
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
S2202 810nm 16W Cluster PRX100 (80x200mW)
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130558 ()


  • Red-light phototherapy unit, professional
S2197 Lollipop Probe
THOR PHOTOMEDICINE LIMITED
2.3
Not in Commercial Distribution

  • 05060494130541 ()


  • Red-light phototherapy unit, professional
S2186 NovoTHOR XL PRX
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130534 ()


  • Red-light phototherapy unit, professional
S2189 NovoTHOR PRX
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130527 ()


  • Red-light phototherapy unit, professional
S2190 NovoTHOR XL
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130510 ()


  • Red-light phototherapy unit, professional
S2188 NovoTHOR
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130503 ()


  • Red-light phototherapy unit, professional
S2186 NovoTHOR Gen 3.0 XL PRX
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130497 ()


  • Red-light phototherapy unit, professional
S2189 NovoTHOR Gen 3.0 Reg PRX
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130480 ()


  • Red-light phototherapy unit, professional
S2190 NovoTHOR Gen 3.0 XL
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130473 ()


  • Red-light phototherapy unit, professional
S2188 NovoTHOR Gen 3.0 Reg
THOR PHOTOMEDICINE LIMITED
3.0
In Commercial Distribution

  • 05060494130466 ()


  • Red-light phototherapy unit, professional
S2195 810nm 16W (80x200mW) - Giant Laser Cluster
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130459 ()


  • Red-light phototherapy unit, professional
S2193 660nm 75mW Dental Probe LiTEFORM PRX
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130442 ()


  • Red-light phototherapy unit, professional
S2169 810nm 1W Cluster (5x200mW) PRX100
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130435 ()


  • Red-light phototherapy unit, professional
S2180 660nm 75mW Dental Probe PRX100
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130428 ()


  • Red-light phototherapy unit, professional
S2099 810nm 200mW Standard Tip - PRX100
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130411 ()


  • Red-light phototherapy unit, professional
S2098 810nm 200mW Dental Probe PRX100
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130404 ()


  • Red-light phototherapy unit, professional
S2093 810nm 200mW Acu Tip PRX100 B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130398 ()


  • Red-light phototherapy unit, professional
S2149 104 LED Cluster Probe PRX100 660nm & 850nm
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130381 ()


  • Red-light phototherapy unit, professional
S2119 69 LED Clust Probe PRX100 660nm & 850nm 1390mW
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130374 ()


  • Red-light phototherapy unit, professional
S2185 BrainTHOR
THOR PHOTOMEDICINE LIMITED
1
In Commercial Distribution

  • 05060494130343 ()


  • Red-light phototherapy unit, professional
S1022 LX2 2.3 Control Unit
THOR PHOTOMEDICINE LIMITED
2.03
In Commercial Distribution

  • 05060494130336 ()


  • Red-light phototherapy unit, professional
S1021 LX2 M Control Unit
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130329 ()


  • Red-light phototherapy unit, professional
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