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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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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

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

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

Homedics - 00031262111753

infrared + red light pain therapy wrap
FKA DISTRIBUTING CO., LLC
IFR-95HJ
In Commercial Distribution

  • 00031262111753 ()


  • Red/infrared light phototherapy unit

HOMEDICS - 00031262110381

Infrared & Red light therapy wrap
FKA DISTRIBUTING CO., LLC
IFR-100HJ
In Commercial Distribution

  • 00031262110381 ()


  • Red/infrared light phototherapy unit

HOMEDICS - 00031262108494

Infrared & Red light therapy
FKA DISTRIBUTING CO., LLC
IFR-100HJ-2
In Commercial Distribution

  • 00031262108494 ()


  • Red/infrared light phototherapy unit

intenseIR - 07898961835099

intenseIR
VYDENCE MEDICAL
18073
In Commercial Distribution

  • 07898961835099 ()
18073

  • Light-energy skin surface treatment system applicator

Phoenix Thera-Lase system - 00008612325047

No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00008612325047 ()


  • Musculoskeletal/physical therapy laser, professional

Richmar TheraTouch - 00092237621059

LX2 Laser Light Clinical Device with cluster applicator
COMPASS HEALTH BRANDS CORP.
DQLLLT
In Commercial Distribution

  • 80092237621055 ()
  • 00092237621059 ()


  • Musculoskeletal/physical therapy laser, professional

Endolaser 120 - 08720618311153

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

  • 08720618311153 ()


  • Musculoskeletal/physical therapy laser, professional

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

Regenesis 3 - G253R30

red/infrared light phototherapy unit
Ochs Labs LLC
1
In Commercial Distribution

  • G253R30 ()


  • Red/infrared light phototherapy unit

e-light I-US - 07898616351400

Laser system for therapy
DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
230020148
In Commercial Distribution

  • 07898616351400 ()
230020148

  • Red/infrared light phototherapy unit

DIOWAVE - G180DIOWAVE250WLS0

No Description
Wuhan PHOMED Technology Co., Ltd.
250WLS
In Commercial Distribution

  • G180DIOWAVE250WLS0 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

DIOWAVE - G180DIOWAVE100WLS0

No Description
Wuhan PHOMED Technology Co., Ltd.
100WLS
In Commercial Distribution

  • G180DIOWAVE100WLS0 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Lumolaser - 08033765391764

The Lumolaser is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000321
In Commercial Distribution

  • 08033765391764 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

HIRO TT US - 08033765391757

The HIRO TT US is an electrically-powered Nd:YAG laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000314
In Commercial Distribution

  • 08033765391757 ()
F9000314

  • Musculoskeletal infrared phototherapy unit, non-wearable

M-Hi D US - 08033765391740

The M-Hi D US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000303
In Commercial Distribution

  • 08033765391740 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

MiS US - 08033765391726

The MiS US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000297
In Commercial Distribution

  • 08033765391726 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

M-Hi US - 08033765391702

The M-Hi US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000296
In Commercial Distribution

  • 08033765391702 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

M7 - 08033765391689

The M7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000290
In Commercial Distribution

  • 08033765391689 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Mphi 7 - 08033765391207

The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It consists of a control unit which may be mounted on a mobile trolley and one or more connected applicator to delivery of visible/infrared laser light energy.
ASA SRL
F9000258
In Commercial Distribution

  • 08033765391207 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

M8 - 08033765391054

No Description
ASA SRL
F9000247
In Commercial Distribution

  • 08033765391054 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

ASA srl - 08033765391023

No Description
ASA SRL
Mphi D
In Commercial Distribution

  • 08033765391023 ()
F9000235

  • Musculoskeletal infrared phototherapy unit, non-wearable

ASA srl - 08033765391016

No Description
ASA SRL
Mphi
In Commercial Distribution

  • 08033765391016 ()
F9000221

  • Musculoskeletal infrared phototherapy unit, non-wearable

ASA srl - 08033765391009

No Description
ASA SRL
M6
In Commercial Distribution

  • 08033765391009 ()
F9000207

  • Musculoskeletal infrared phototherapy unit, non-wearable

Phoenix Thera-Lase system - 00086001232503

No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00086001232503 ()


  • Musculoskeletal/physical therapy laser, professional

INFRABALDAN - 08053782383313

No Description
B&M SRL MARKETING NEL BENESSERE
INFRABALDAN
In Commercial Distribution

  • 08053782383313 ()


  • Red/infrared light phototherapy unit

BioStimul Handpiece - 08034108512419

The BioStimul Handpiece is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscolar and joint pain and stiffness, minor arthrits pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles. The spot diameter at 1 cm out of the handpiece is 5 mm. The BioStimul Handpiece is supplied together with a suitable optical fiber.
DEKA M.E.L.A. SRL
N378C1
In Commercial Distribution

  • 08034108512419 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable

Ixyon XP F30 - 08051499975050

The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis. It is also indicated for promoting relaxation of the muscle tissue and for temporarily increasing local blood circulation.
MECTRONIC MEDICALE SRL
1IXF30
In Commercial Distribution

  • 08051499975050 ()


  • Musculoskeletal/physical therapy laser, professional

Ixyon XP F16 - 08051499975043

The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis. It is also indicated for promoting relaxation of the muscle tissue and for temporarily increasing local blood circulation.
MECTRONIC MEDICALE SRL
1IXF16
In Commercial Distribution

  • 08051499975043 ()


  • Musculoskeletal/physical therapy laser, professional

iLux LF HPS V25 - 08051499974374

The device is emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis. It is also indicated for promoting relaxation of the muscle tissue and for temporarily increasing local blood circulation.
MECTRONIC MEDICALE SRL
1LFHV25
In Commercial Distribution

  • 08051499974374 ()


  • Musculoskeletal/physical therapy laser, professional
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