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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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LS Pro Systems Boot Pad 112 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
B112
In Commercial Distribution

  • 00850061407115 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Head Pad 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
In Commercial Distribution

  • 00850061407108 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Target Pad 90 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
T90
In Commercial Distribution

  • 00850061407092 ()


  • Red/infrared light phototherapy unit
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
Del Sol Red Cordless LED Light for EU/CE only
Hydrafacial LLC
Cordless (EU)
In Commercial Distribution

  • 00850043007340 ()
  • 00850043007357 ()
70393-01

  • Cosmetic red-light phototherapy system, professional
Red LED Handpiece with Power Supply
Hydrafacial LLC
Power Supply
In Commercial Distribution

  • 00850043007043 ()
70238

  • Cosmetic red-light phototherapy system, professional
Red LED Handpiece, 12V
Hydrafacial LLC
12V
In Commercial Distribution

  • 00850043007029 ()
70237

  • Cosmetic red-light phototherapy system, professional
Red Cordless LED - US
Hydrafacial LLC
Cordless (US)
In Commercial Distribution

  • 00850043007005 ()
70393

  • Cosmetic red-light phototherapy system, professional
No Description
LUMITON MEDICAL PRODUCTS LLC
Cool Tangerine
In Commercial Distribution

  • 00850056402446 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
LUMITON MEDICAL PRODUCTS LLC
Fire Orange
In Commercial Distribution

  • 00850056402439 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
LUMITON MEDICAL PRODUCTS LLC
Tidal Wave
In Commercial Distribution

  • 00850056402422 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
LUMITON MEDICAL PRODUCTS LLC
Steel Grey
In Commercial Distribution

  • 00850056402415 ()


  • Musculoskeletal/physical therapy laser, home-use
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