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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Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-X
Not in Commercial Distribution

  • 00852116008018 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1.5 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-Z
Not in Commercial Distribution

  • 00852116008001 ()


  • Musculoskeletal/physical therapy laser, 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 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
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
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
WALG RED LIGHT THERAPY HANDHELD UNIT
WALGREEN CO.
745309
In Commercial Distribution

  • 00311917214863 ()
  • 10311917214860 ()


  • Musculoskeletal infrared phototherapy unit, wearable
WALG RED LIGHT THERAPY UNIT
WALGREEN CO.
745308
In Commercial Distribution

  • 00311917214856 ()
  • 10311917214853 ()


  • Musculoskeletal infrared phototherapy unit, wearable
No Description
BLUBLOX PTY LTD
Red Light Face Wand
In Commercial Distribution

  • 09361725000081 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Mini Red Light Therapy Device
In Commercial Distribution

  • 09361725000074 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Therapy Blanket
In Commercial Distribution

  • 09361725000067 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Neck and Chest Mask
In Commercial Distribution

  • 09361725000050 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Face Mask
In Commercial Distribution

  • 09361725000043 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Super Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000036 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000029 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Demi Red Light Therapy Device
In Commercial Distribution

  • 09361725000012 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Bullet Red Light Therapy Device
In Commercial Distribution

  • 09361725000005 ()


  • Cosmetic red-light phototherapy system, home-use
Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Touch OrthoPhys -Trolley version (12000). This device is Laserneedle Touch Orthophys with 5 Red (5R) and 5 Infra red (5IR) lasers. Under the scope of delivery of the Laserneedle device package are included the following accessories / consumables / spare parts: - Regular optical fiber (Product number: 40200; Primary DI number: 4260649160244) - Quartz optical fiber (Product number: 40300 Primary DI number: 4260649160275) - Trolley with power supply (Product number: 35000 Primary DI number: 4260649160213) - Laser protection goggles (Product number: 32010 Primary DI number: 4260649160305) - LN Tape (Product number: 40100 Primary DI number: 4260649160466) - Self adhesive applicator (Product number: 40510 Primary DI number: 4260649160404) - LN Tip caps (Product number: 40710 Primary DI number: 4260649160503) - Set of silicon pads (Product number: 40600; Primary DI number: 4260649160312) - Silicone applicators (Product number: 40410; Primary DI number: 4260649160411)
Laserneedle GmbH
12000-Trolley
In Commercial Distribution

  • 04260649160046 ()


  • Musculoskeletal/physical therapy laser, 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
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