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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Priori UnveiLED Neck & Decollete
I-SMART DEVELOPMENTS LIMITED
TN2037
In Commercial Distribution

  • 05060534510586 ()
112A

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

  • 05060534510203 ()
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
HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain. TDP22-XL represents a type of TDP heat lamp upright with double heads, mechanical timer and small plate.
Suzhou Medical Appliance Factory
TDP22-XL
In Commercial Distribution

  • 06901452000058 ()

  • Weight: 12 Kilogram


  • Musculoskeletal infrared phototherapy unit, non-wearable
HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain. TDP12-XL represents a type of TDP heat lamp upright with single head, mechanical timer and small plate.
Suzhou Medical Appliance Factory
TDP12-XL
In Commercial Distribution

  • 06901452000010 ()

  • Weight: 9 Kilogram


  • Musculoskeletal infrared phototherapy unit, non-wearable
HWATO TDP Heat Lamp is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain. TDP11-DL represents a type of TDP heat lamp upright with single head, digital timer and big plate.
Suzhou Medical Appliance Factory
TDP11-DL
In Commercial Distribution

  • 06901452000003 ()

  • Weight: 9 Kilogram


  • Musculoskeletal infrared phototherapy unit, non-wearable
Goggle ASSY (For patient) of HEALITE II / Rubber goggle
Lutronic Corporation
Goggle ASSY (For patient)
In Commercial Distribution

  • 08809447652122 ()


  • Red-light phototherapy unit, professional
Healite II Arm (Arn)
Lutronic Corporation
Arm
In Commercial Distribution

  • 8809447651736 ()
  • 08809447651729 ()


  • Red-light phototherapy unit, professional
Healite II Manual (Operator's Manual)
Lutronic Corporation
Manual
In Commercial Distribution

  • 08809447651712 ()


  • Red-light phototherapy unit, professional
Healite Body Assy (System Main Body)
Lutronic Corporation
Healite Body Assy
In Commercial Distribution

  • 8809447651705 ()
  • 08809447651699 ()


  • Red-light phototherapy unit, professional
Healite II 830&590nm Head (830/590nm head)
Lutronic Corporation
830&590nm Head
In Commercial Distribution

  • 8809447651682 ()
  • 08809447651675 ()


  • Red-light phototherapy unit, professional
The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environment. It provides extra warmth for Infant patients when they are out of the bassinet for examination, bathing, weighing, feeding, or minor procedures.Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows the user to confirm a safe minimum distance from the heat source, while the intensity control allows the user to set just the right level of radiant heat.
NATUS MEDICAL INCORPORATED
Model 45
In Commercial Distribution

  • 00382830047036 ()
56845

  • Infant warmer
The Olympic Warm-Lamp Model 41/45 is a source of controllable heat in the patient care environment. It provides extra warmth for Infant patients when they are out of the bassinet for examination, bathing, weighing, feeding, or minor procedures.Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows the user to confirm a safe minimum distance from the heat source, while the intensity control allows the user to set just the right level of radiant heat.
NATUS MEDICAL INCORPORATED
Model 41
In Commercial Distribution

  • 00382830005470 ()
56841

  • Infant warmer
"The Olympic Warm-Lamp Model 31 is a source of controllable heat in the patient care environment. It provides extra warmth for infant patients when out of the bassinet for examination, bathing, weighing, feeding, or minor procedures. Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows you to confirm a safe minimum distance from the heat source, while the intensity control allows you to set just the right level of radiant heat. feeding, or minor procedures."
NATUS MEDICAL INCORPORATED
Model 31
In Commercial Distribution

  • 00382830005463 ()
56831

  • Infant warmer
No Description
GTG Wellness Co., Ltd.
BBL-100 FULLSET
Not in Commercial Distribution

  • 08809520341608 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OMZ-100 NECK
Not in Commercial Distribution

  • 08809520341165 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OMZ-100 FULLSET
Not in Commercial Distribution

  • 08809520341134 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OLZ-200 FULLSET
Not in Commercial Distribution

  • 08809520341103 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OLG-100 Neck
Not in Commercial Distribution

  • 08809520341066 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OLG-100 FULLSET
Not in Commercial Distribution

  • 08809520341035 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OLG-200 FULLSET
Not in Commercial Distribution

  • 08809520341004 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OMZ-100 FACE MASK
Not in Commercial Distribution

  • 08809520341141 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OLZ-200 FACE MASK
Not in Commercial Distribution

  • 08809520341110 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
OLG-100 Face Mask
Not in Commercial Distribution

  • 08809520341042 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
CONTROLLER
Not in Commercial Distribution

  • 08809520341028 ()


  • Blue/red/infrared phototherapy lamp
No Description
GTG Wellness Co., Ltd.
FACE MASK
Not in Commercial Distribution

  • 08809520341011 ()


  • Blue/red/infrared phototherapy lamp
Tommie Copper Hand & Wrist Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-ST-58-HM
In Commercial Distribution

  • 00843041143172 ()


  • Red/infrared light phototherapy unit
Tommie copper Infrared&Red Light Pain Therapy Wrap
Shenzhen Kaiyan Medical Equipment Co,. Ltd
5010LD
In Commercial Distribution

  • 00843041137164 ()
  • 00843041136907 ()


  • Musculoskeletal infrared phototherapy unit, wearable
Tommie copper Infrared &Red light contour therapy wrap
Shenzhen Kaiyan Medical Equipment Co,. Ltd
5008LD
In Commercial Distribution

  • 00843041137119 ()
  • 00843041136433 ()


  • Musculoskeletal infrared phototherapy unit, wearable
Tommie Copper Shoulder Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-ZLD-60-X-SW
In Commercial Distribution

  • 00843041125857 ()


  • Red/infrared light phototherapy unit
Tommie Copper Neck Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-ZLD-46-NP
In Commercial Distribution

  • 00843041125840 ()


  • Red/infrared light phototherapy unit
Tommie Copper Joint Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-HX-60B-JW
In Commercial Distribution

  • 00843041125833 ()


  • Red/infrared light phototherapy unit
Tommie Copper Back Wrap
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
TC-ZLD-60V-BW
In Commercial Distribution

  • 00843041125826 ()


  • Red/infrared light phototherapy unit
No Description
Vielight Inc
RLF
In Commercial Distribution

  • 00196852718429 ()


  • Red/infrared light phototherapy unit
No Description
Powermedic ApS
45156
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45155
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45151
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45056
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45055
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
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