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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64-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-64R
In Commercial Distribution

  • 00858935006457 ()
602018

  • Musculoskeletal infrared phototherapy unit, non-wearable
Two Port CAREController - Infrared Phototherapy control device for up to 2 phototherapy emitters
HEALTHLIGHT LLC
CL-C2
In Commercial Distribution

  • 00858935006440 ()
602017

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot & Calf Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-NP
In Commercial Distribution

  • 00858935006426 ()
602015

  • Musculoskeletal infrared phototherapy unit, non-wearable
264-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-264R
In Commercial Distribution

  • 00858935006419 ()
602014

  • Musculoskeletal infrared phototherapy unit, non-wearable
132-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-132R
In Commercial Distribution

  • 00858935006396 ()
602012

  • Musculoskeletal infrared phototherapy unit, non-wearable
90-LED Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-90R
In Commercial Distribution

  • 00858935006389 ()
602011

  • Musculoskeletal infrared phototherapy unit, non-wearable
Lumen MD Foot and Hand Pad System
HEALTHLIGHT LLC
LM-CP-S
In Commercial Distribution

  • 00858935006372 ()
602009

  • Musculoskeletal infrared phototherapy unit, non-wearable
Lumen MD Dual Foot and Ankle System
HEALTHLIGHT LLC
LM-NP2-S
In Commercial Distribution

  • 00858935006358 ()
602008

  • Musculoskeletal infrared phototherapy unit, non-wearable
Dual Foot And Calf Pad System
HEALTHLIGHT LLC
HL-NP2-S
In Commercial Distribution

  • 00858935006280 ()
502034

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot and Calf Pad System
HEALTHLIGHT LLC
HL-NP-S
In Commercial Distribution

  • 00858935006273 ()
502033

  • Musculoskeletal infrared phototherapy unit, non-wearable
64 LED Infrared Phototherapy Pad
HEALTHLIGHT LLC
HL-64R
In Commercial Distribution

  • 00858935006259 ()
502031

  • Musculoskeletal infrared phototherapy unit, non-wearable
Dual Foot & Ankle Infrared Phototherapy System
HEALTHLIGHT LLC
HL-PB2-S
In Commercial Distribution

  • 00858935006228 ()
502029

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot and Ankle Pad System
HEALTHLIGHT LLC
HL-PB-S
In Commercial Distribution

  • 00858935006204 ()
502028

  • Musculoskeletal infrared phototherapy unit, non-wearable
Healthlight Large Pad System
HEALTHLIGHT LLC
HL-264-S
In Commercial Distribution

  • 00858935006181 ()
502026

  • Musculoskeletal infrared phototherapy unit, non-wearable
Healthlight Medium Pad System
HEALTHLIGHT LLC
HL-132-S
In Commercial Distribution

  • 00858935006167 ()
502024

  • Musculoskeletal infrared phototherapy unit, non-wearable
Brain Tap 132 Pad System
HEALTHLIGHT LLC
BT-132-S
In Commercial Distribution

  • 00858935006143 ()
502022

  • Musculoskeletal infrared phototherapy unit, non-wearable
Russell Distribution Headband Infrared Phototherapy System
HEALTHLIGHT LLC
RD-HB-S
In Commercial Distribution

  • 00858935006129 ()
502020

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot and Ankle Pad, DIN connector, Infrared Phototherapy unit
HEALTHLIGHT LLC
HL-PBD
In Commercial Distribution

  • 00858935006105 ()
502011

  • Musculoskeletal infrared phototherapy unit, non-wearable
Three Port Controller, Infrared Phototherapy Unit
HEALTHLIGHT LLC
HL-C3
In Commercial Distribution

  • 00858935006082 ()
502008, 502039, 502050

  • Musculoskeletal infrared phototherapy unit, non-wearable
LED infrared light therapy wrap for amputees
PHYSIOHAB LLC
OLKA3003
In Commercial Distribution

  • 00860013229085 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy wrap for the elbow
PHYSIOHAB LLC
OLE3006
In Commercial Distribution

  • 00860013229078 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the foot
PHYSIOHAB LLC
OLF3009
In Commercial Distribution

  • 00860013229061 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared light therapy wrap for the ankle
PHYSIOHAB LLC
OLA3001
In Commercial Distribution

  • 00860013229054 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the Neck
PHYSIOHAB LLC
OLN3004
In Commercial Distribution

  • 00860013229030 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the lumbar
PHYSIOHAB LLC
OLL3003
In Commercial Distribution

  • 00860013229009 ()


  • Blue/red/infrared phototherapy lamp
No Description
Silhouet-Tone Corporation
411560
In Commercial Distribution

  • 00667259001952 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
IVIMEA
IR-20
In Commercial Distribution

  • 00866085000409 ()


  • Musculoskeletal/physical therapy laser, professional
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
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 & 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
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