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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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
SL Single Probe
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-002
In Commercial Distribution

  • 00859626006275 ()
ML-830-07-002

  • Musculoskeletal/physical therapy laser, home-use
No Description
ANODYNE THERAPY, L.L.C.
120-2
In Commercial Distribution

  • 00859101006097 ()
498011

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
480 Recertified
In Commercial Distribution

  • 00859101006042 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
480
In Commercial Distribution

  • 00859101006035 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120 Professional
In Commercial Distribution

  • 00859101006028 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120 Recertified
In Commercial Distribution

  • 00859101006011 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The first wearable, wireless LED light patches for athletes in all sports: on the training field, on the road, even at home. CareWear Light Patches start relieving pain and accelerating recovery in just 30 minutes.
ZMI ELECTRONICS LTD.
CWC-1
In Commercial Distribution

  • 44719872330491 ()
  • 04719872330479 ()
  • 14719872330483 ()
  • 04719872330585 ()
  • 04719872330578 ()


  • Musculoskeletal/physical therapy laser, home-use
a cosmetic outlook improved version if compare with the previous ABPT1003 device. so, this is a Mark II version with slight change to the machine outlook.
APPLIED BIOPHOTONICS LIMITED
ABPT1003-2
In Commercial Distribution

  • 04719873240029 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
APPLIED BIOPHOTONICS LIMITED
ABPT1003
In Commercial Distribution

  • 04719873240012 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
Infrared Light Therapy Lamp
Beijing Choice Electronic Technology Co., Ltd.
CILTL1A1
In Commercial Distribution

  • 00846841012617 ()


  • Blue/red/infrared phototherapy lamp
Apollo laser handheld
PIVOTAL HEALTH SOLUTIONS, INC.
Handheld, HH
In Commercial Distribution

  • 00852753008969 ()


  • Musculoskeletal/physical therapy laser, home-use
Apollo portable laser system
PIVOTAL HEALTH SOLUTIONS, INC.
Portable, AP2-PT
In Commercial Distribution

  • 00852753008891 ()


  • Musculoskeletal/physical therapy laser, home-use
Desktop laser
PIVOTAL HEALTH SOLUTIONS, INC.
Desktop AP2-DT
In Commercial Distribution

  • 00852753008884 ()


  • Musculoskeletal/physical therapy laser, professional
Infrared Lamp
BEURER NORTH AMERICA, L.P.
IL50
In Commercial Distribution

  • 10852547004105 ()
  • 00852547004108 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm.
QUASAR BIO-TECH INC.
DPA-027
In Commercial Distribution

  • 00851478007226 ()
DPA-027

  • Blue/red/infrared phototherapy lamp
3-Port System w/ Mega Trifold Panel 1716 Total LED's (1,092 color + 624 IR)
Innovative Med
IM-MWL-1716
In Commercial Distribution

  • 00851314007090 ()
IM-MWL-1716

  • Blue/red/infrared phototherapy lamp
LS Pro Systems Face Pad 104 blue/red/ LED flexi-pad. Intended to emit both red and blue light for the treatment of a facial skin conditions and help with mood, circadian rhythm, sleep, and relaxation. It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin. Promotes circulation at the skin level and can increase elasticity/collagen. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
F104
In Commercial Distribution

  • 00850061407085 ()


  • Red/blue light phototherapy unit
LS Pro Systems Local Pad Blue 132 blue/infrared LED flexi-pad. Intended to deliver light in blue and infrared spectrums to the skin to help kill off acne-causing bacteria and reduces activity in oil-secreting glands; It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin and can benefit skin elasticity. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
L132B
In Commercial Distribution

  • 00850061407078 ()


  • Blue-light phototherapy lamp, home-use
LS Pro Systems Local Pad 132 red/infrared LED flexi-pad. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
L132
In Commercial Distribution

  • 00850061407061 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Body pad XL 200 red/infrared LED flexi-pad with PEMF. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sciatica, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. It is intended to be applied to the body and emit short-time pulsed, radio-frequency energy [pulsed electromagnetic fields (PEMF)] to tissues at a level below the patient's heat sensory perception threshold. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
XL200
In Commercial Distribution

  • 00850061407054 ()


  • Hand-held deep-tissue electromagnetic stimulator
LS Pro Systems General Blue 264 blue/infrared LED flexi-pad. Intended to deliver light in blue and infrared spectrums to the skin to help kill off acne-causing bacteria and reduces activity in oil-secreting glands; It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin and can benefit skin elasticity. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
G264B
In Commercial Distribution

  • 00850061407047 ()


  • Blue-light phototherapy lamp, home-use
LS Pro Systems General Red 264 red/infrared LED flexi-pad. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
G264
In Commercial Distribution

  • 00850061407030 ()


  • Red/infrared light phototherapy unit
LS Pro Systems 6 Port Controller power supply for LS Pro Systems LED therapeutic pad
WELLNESS WITHOUT LIMITS LLC
XP6
In Commercial Distribution

  • 00850061407023 ()


  • Red/infrared light phototherapy unit
LS Pro Systems 3 Port Controller power supply for LS Pro Systems LED therapeutic pad
WELLNESS WITHOUT LIMITS LLC
XP3
In Commercial Distribution

  • 00850061407016 ()


  • Red/infrared light phototherapy unit
LS Pro Systems 1 Port Controller power supply for LS Pro Systems LED therapeutic pad
WELLNESS WITHOUT LIMITS LLC
XP1
In Commercial Distribution

  • 00850061407009 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Face Pad in Silicone 122 blue/red/ LED flexi-pad. Intended to emit both red and blue light for the treatment of a facial skin conditions and help with mood, circadian rhythm, sleep, and relaxation. It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin. Promotes circulation at the skin level and can increase elasticity/collagen. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
F122-SI
In Commercial Distribution

  • 00850061407214 ()


  • Red/blue light phototherapy unit
LS Pro Systems Deep Light Therapy System Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Comes with power controller cord.
WELLNESS WITHOUT LIMITS LLC
DSD120
In Commercial Distribution

  • 00850061407207 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Lower back Pad 114 red/infrared LED flexi-pad. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
LB114-SI
In Commercial Distribution

  • 00850061407191 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Upper back/neck Pad 128 red/infrared LED flexi-pad. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
UB128-SI
In Commercial Distribution

  • 00850061407184 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Head Pad in Silicone 155 red/infrared LED flexi-pad. Intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Must be used with LS power controller.
WELLNESS WITHOUT LIMITS LLC
H155-SI
In Commercial Distribution

  • 00850061407177 ()


  • Red/infrared light phototherapy unit
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