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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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Walgreens - 00311917214856

WALG RED LIGHT THERAPY UNIT
WALGREEN CO.
745308
In Commercial Distribution

  • 00311917214856 ()
  • 10311917214853 ()


  • Musculoskeletal infrared phototherapy unit, wearable

PREMIO 10 MOXA - 03760262493107

The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
SEDATELEC
PREMIO 10
Not in Commercial Distribution

  • 03760262493107 ()
111237

  • Musculoskeletal infrared phototherapy unit, non-wearable

Endolaser 120 - 08720618311153

Device for low level laser therapy
Enraf-Nonius B.V.
1633931
In Commercial Distribution

  • 08720618311153 ()


  • Musculoskeletal/physical therapy laser, professional

Platinum LED Therapy Lights - B842BIOMAX9000

BIOMAX900
PLATINUM LED HOLDINGS LLC
BIOMAX900
In Commercial Distribution

  • B842BIOMAX9000 ()

  • 900w
  • 36" x 12" x 3"
  • Weight: 33 Pound
BIOMAX900

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIOMAX6000

BIOMAX600
PLATINUM LED HOLDINGS LLC
BIOMAX600
In Commercial Distribution

  • B842BIOMAX6000 ()

  • 600w
  • 36" x 9" x 3"
  • Weight: 22 Pound
BIOMAX600

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIOMAX4500

BIOMAX450
PLATINUM LED HOLDINGS LLC
BIOMAX450
In Commercial Distribution

  • B842BIOMAX4500 ()

  • 450w
  • 19" x 12" x 3"
  • Weight: 17 Pound
BIOMAX450

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIOMAX3000

Biomax 300
PLATINUM LED HOLDINGS LLC
BIOMAX300
In Commercial Distribution

  • B842BIOMAX3000 ()

  • 300w
  • 19" x 9" x 3"
  • Weight: 11 Pound
BIOMAX300

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO900RNIR0

BIO900RNIR
PLATINUM LED HOLDINGS LLC
BIO900RNIR
In Commercial Distribution

  • B842BIO900RNIR0 ()

  • 900w
  • 36"x12"x3"
  • Weight: 33 Pound
BIO900RNIR

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO900R0

BIO900R
PLATINUM LED HOLDINGS LLC
BIO900R
In Commercial Distribution

  • B842BIO900R0 ()

  • 900w
  • 36"x12"x3"
  • Weight: 33 Pound
BIO900R

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO900NIR0

BIO900NIR
PLATINUM LED HOLDINGS LLC
BIO900NIR
In Commercial Distribution

  • B842BIO900NIR0 ()

  • 900w
  • 36"x12"x3"
  • Weight: 33 Pound
BIO900NIR

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO600RNIR0

BIO600RNIR
PLATINUM LED HOLDINGS LLC
BIO600RNIR
In Commercial Distribution

  • B842BIO600RNIR0 ()

  • 36"x9"x3"
  • 600w
  • Weight: 22 Pound
BIO600RNIR

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO600R0

BIO600R
PLATINUM LED HOLDINGS LLC
BIO600R
In Commercial Distribution

  • B842BIO600R0 ()

  • 600w
  • 36"x9"x3"
  • Weight: 22 Pound
BIO600R

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO600NIR0

BIO600NIR
PLATINUM LED HOLDINGS LLC
BIO600NIR
In Commercial Distribution

  • B842BIO600NIR0 ()

  • 36"x9"x3"
  • Weight: 22 Pound
  • 600w
BIO600NIR

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO450RNIR0

BIO450RNIR
PLATINUM LED HOLDINGS LLC
BIO450RNIR
In Commercial Distribution

  • B842BIO450RNIR0 ()

  • 450w
  • 19"x11"x3"
  • Weight: 17 Pound
BIO450RNIR

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO450R0

BIO450R
PLATINUM LED HOLDINGS LLC
BIO450R
In Commercial Distribution

  • B842BIO450R0 ()

  • 450w
  • 19"x11"x3"
  • Weight: 17 Pound
BIO450R

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO450NIR0

BIO450NIR
PLATINUM LED HOLDINGS LLC
BIO450NIR
In Commercial Distribution

  • B842BIO450NIR0 ()
BIO450NIR

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO300RNIR0

BIO300RNIR
PLATINUM LED HOLDINGS LLC
BIO300RNIR
In Commercial Distribution

  • B842BIO300RNIR0 ()

  • 300w
  • 19" x 9" x 3"
  • Weight: 11 Pound
BIO300RNIR

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO300R0

BIO300R
PLATINUM LED HOLDINGS LLC
BIO300R
In Commercial Distribution

  • B842BIO300R0 ()

  • 300w
  • 19"X9"X3"
  • Weight: 11 Pound
BIO300R

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO300NIR0

BIO300NIR
PLATINUM LED HOLDINGS LLC
BIO300NIR
In Commercial Distribution

  • B842BIO300NIR0 ()

  • 300w
  • 19"x9"x3"
  • Weight: 11 Pound
BIO300NIR

  • Blue/red/infrared phototherapy lamp

Wonder Double Head TDP Heat Lamp - 00818318028186

This lamp features a proprietary mineral plate to emit far infrared band
Prime Holly Corporation
L11
In Commercial Distribution

  • 00818318028186 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Wonder TDP Heat Lamp - 00818318028179

This lamp features a proprietary mineral plate to emit far infrared band
Prime Holly Corporation
L03
In Commercial Distribution

  • 00818318028179 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Wonder TDP Heat Lamp - 00818318028162

This lamp features a proprietary mineral plate to emit far infrared band
Prime Holly Corporation
L02
In Commercial Distribution

  • 00818318028162 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

intenseIR - 07898961835099

intenseIR
VYDENCE MEDICAL
18073
In Commercial Distribution

  • 07898961835099 ()
18073

  • Light-energy skin surface treatment system applicator

Platinum - B679SLP4H0

Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
P4H
In Commercial Distribution

  • B679SLP4H0 ()
SLP4H

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679SLP40

Light weight (~3 Kg.) and portable therapeutic medical laser device (measuring ~195 mm x 195 mm x 275 mm) indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments are in the form of non-ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
SLP4
In Commercial Distribution

  • B679SLP40 ()
SLP4

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679SLP30

Light weight (~2 Kg.) and portable therapeutic medical laser device (measuring ~225 mm x 150 mm x 150 mm) indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments are in the form of non-ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
SLP3
In Commercial Distribution

  • B679SLP30 ()
SLP3

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679SLP10

Light weight (~3 Kg.) and portable therapeutic medical laser device (measuring ~195 mm x 195 mm x 275 mm) indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments are in the form of non-ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
SLP1
In Commercial Distribution

  • B679SLP10 ()
SLP1

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679SLH10

Light weight (~2 Kg.) and portable therapeutic medical laser device (measuring ~225 mm x 150 mm x 150 mm) indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments are in the form of non-ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
SLH1
In Commercial Distribution

  • B679SLH10 ()
SLH1

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679KP40

Therapeutic medical laser device indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.The noninvasive laser treatments are in the form of non ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA.The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair.The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste.The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
KP4
Not in Commercial Distribution

  • B679KP40 ()
KP4

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679KP30

Therapeutic medical laser device indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.The noninvasive laser treatments are in the form of non ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA.The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair.The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste.The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
KP3
Not in Commercial Distribution

  • B679KP30 ()
KP3

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679KP10

Therapeutic medical laser device indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.The noninvasive laser treatments are in the form of non ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA.The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair.The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste.The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
KP1
In Commercial Distribution

  • B679KP10 ()
KP1

  • Musculoskeletal/physical therapy laser, professional

Platinum - B679KGH10

Therapeutic medical laser device indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.The noninvasive laser treatments are in the form of non ionizing radiation in which the invisible light wave doses and visible light wave aiming beam are not cumulative and do not create changes in cellular DNA.The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair.The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste.The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
KGH1
Not in Commercial Distribution

  • B679KGH10 ()
KGH1

  • Musculoskeletal/physical therapy laser, professional

Dynatron 880Plus Infrared Cluster Probe - 10660584000437

No Description
Dynatronics Corporation
D881
Not in Commercial Distribution

  • 10660584000437 ()

  • Weight: 0.5 Pound


  • Light-energy skin surface treatment system applicator

Dynatron Tri-Wave Light Probe - 10660584000154

No Description
Dynatronics Corporation
DCP3
In Commercial Distribution

  • 10660584000154 ()

  • Weight: 0.6 Pound


  • Light-energy skin surface treatment system applicator

LZR7 - B657003

No Description
LZR7, INC.
Ultrabright
In Commercial Distribution

  • B657003 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

LZR7 - B657002

Pro3M Laser Unit
LZR7, INC.
Pro3M
In Commercial Distribution

  • B657002 ()


  • Musculoskeletal/physical therapy laser, home-use

LZR7 - B657001

ZX2 Laser Unit
LZR7, INC.
ZX2
In Commercial Distribution

  • B657001 ()


  • Musculoskeletal/physical therapy laser, home-use

Homedics - 00031262115454

No Description
Zhangzhou Easepal Medical Science And Technology Co., Ltd.
IFR-571HJ-10PK
In Commercial Distribution

  • 00031262115454 ()


  • Blue/red/infrared phototherapy lamp

Homedics - 00031262114518

infrared + red light pain therapy wrap
FKA DISTRIBUTING CO., LLC
IFR-99HJ
In Commercial Distribution

  • 00031262114518 ()


  • Red/infrared light phototherapy unit

HOMEDICS - 00031262111760

infrared + red light pain therapy wrap
FKA DISTRIBUTING CO., LLC
IFR-97HJ
In Commercial Distribution

  • 00031262111760 ()


  • Red/infrared light phototherapy unit
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