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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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
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
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
No Description
LUMITON MEDICAL PRODUCTS LLC
Coral
In Commercial Distribution

  • 00850056402408 ()


  • Musculoskeletal/physical therapy laser, home-use
Collagentex Rx-3 NIR device, model Rx-3, 3 lamp module
Tanses Technologies Inc
Rx-3
In Commercial Distribution

  • 00850056256438 ()


  • Red-light phototherapy unit, professional
Collagentex Rx-2 NIR device, model Rx-2, 2 lamp module
Tanses Technologies Inc
Rx-2
In Commercial Distribution

  • 00850056256421 ()


  • Red-light phototherapy unit, professional
Collagentex Rx-1-Seat NIR device, Seat version, model Rx-1-Seat, 1 lamp module
Tanses Technologies Inc
RX-1-Seat
In Commercial Distribution

  • 00850056256414 ()


  • Red-light phototherapy unit, professional
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 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
LS Pro Systems Body pad XL in Silicone 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-SI
In Commercial Distribution

  • 00850061407160 ()


  • Hand-held deep-tissue electromagnetic stimulator
LS Pro Systems General Red in Silicone 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-SI
In Commercial Distribution

  • 00850061407153 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Full Body Large Power Light Bed 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.
WELLNESS WITHOUT LIMITS LLC
PB-MXP171
In Commercial Distribution

  • 00850061407139 ()


  • Red/infrared light phototherapy unit
LS Pro Systems Full Body Power Light Bed 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.
WELLNESS WITHOUT LIMITS LLC
PB-MXP100
In Commercial Distribution

  • 00850061407122 ()


  • Red/infrared light phototherapy unit
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
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
No Description
BLUBLOX PTY LTD
Red Light Face Wand
In Commercial Distribution

  • 09361725000081 ()


  • Cosmetic red-light phototherapy system, home-use
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