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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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MedX Rehab Portable Laser - 00628451918233

The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0915
In Commercial Distribution

  • 00628451918226 ()
  • 00628451918233 ()
  • 70628451918232 ()
  • 40628451918231 ()
  • 50628451918238 ()
  • 30628451918234 ()
  • 20628451918237 ()

  • Weight: 113 Gram


  • Musculoskeletal/physical therapy laser, professional

MedX Acupuncture Portable Laser - 00628451918219

The Acupuncture Portable Laser delivers high-quality auricular laser acupuncture therapy. The device features one GaAIAs near-infrared laser diode and three visible red LEDs and a special fiber optic light guide tip that deliver low level laser & light therapy to very small trigger points on the ear. The Acupuncture Portable Laser has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0912
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918219 ()
  • 50628451918214 ()
  • 30628451918210 ()
  • 20628451918213 ()

  • Weight: 190 Gram


  • Musculoskeletal/physical therapy laser, professional

MedX Oralase Portable Laser - 00628451918202

The Oralase Portable Portable Laser delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. The device features one GaAIAs near-infrared laser diode and three visible red guide LEDs that deliver laser & light therapy. The Oralase Portable Laser has been designed for licensed or certified healthcare professionals.
MedX Health Corp
0910
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918202 ()
  • 60628451918204 ()
  • 40628451918200 ()
  • 50628451918207 ()
  • 30628451918203 ()
  • 20628451918206 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Home Unit - Light Therapy system - 00628451918189

The MedX Brand Light Therapy home unit is a light therapy system for home use. It is used by the patient to treat a variety of medical conditions such a chronic pain, swelling, inflammation, bruising, wound healing, and much more. The device utilizes an LED light diode cluster that contain a large number of red light diodes. The cluster can be attached to the skin surface with the velcro straps prior to beginning a treatment.
MedX Health Corp
2031
In Commercial Distribution

  • 00628451918189 ()
  • 00628451918165 ()
  • 50628451918184 ()
  • 30628451918180 ()
  • 20628451918183 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Rehab Console System - 00628451918158

The MedX Rehab Console System is a therapeutic Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers the high quality handheld laser therapy device and also two SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader treatment applications. This accessory can be strapped to the body for "hands-free" unattended treatment.
MedX Health Corp
3116
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918158 ()
  • 30628451918159 ()
  • 50628451918153 ()
  • 20628451918152 ()
  • 40628451918156 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Rehab Console System - 00628451918141

The MedX Rehab Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing and many other conditions that require therapy. . The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM 1100N console powers the one (1) laser therapy device.
MedX Health Corp
3114
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918141 ()
  • 50628451918146 ()
  • 30628451918142 ()
  • 20628451918145 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Rehab Console System - 00628451918127

The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruise and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers three SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader variety of applications. This Cluster accessories can be strapped to the body for "hands-free" unattended treatment.
MedX Health Corp
3110
In Commercial Distribution

  • 00628451918103 ()
  • 00628451918127 ()
  • 50628451918122 ()
  • 30628451918128 ()
  • 20628451918121 ()
  • 10628451918124 ()


  • Musculoskeletal/physical therapy laser, professional

SLD Light cluster - 00628451918417

The MedX SLD Light diode Cluster, with an output power of 500mW, is used together with the Richmar console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
MCT 507
In Commercial Distribution

  • 00628451918417 ()
  • 00628451918400 ()
  • 60628451918419 ()
  • 20628451918411 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Rehab Portable Laser - 00628451918394

The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals. This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.
MedX Health Corp
0455
In Commercial Distribution

  • 00628451918387 ()
  • 00628451918394 ()
  • 90628451918397 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Rehab Portable Laser - 00628451918356

The MedX Rehab Laser cluster, stand alone, LCS 450, is a battery powered laser medical device accessory and is part of MedX Health kit Item # 0915. The hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. ) This registration is to show the UDI for direct marking and primary packaging when this product shipped as a particular item, e.g. replacement or repaired unit, and not as a kit.
MedX Health Corp
LCS450
In Commercial Distribution

  • 00628451918356 ()
  • 00628451918226 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Oralase Portable Laser - 00628451918349

The Oralase Portable Laser, LPS200, delivers high-quality laser & light therapy for Oralase applications.The laser can be used in a variety of procedures to reduce pain, swelling, bleeding, bruising and other conditions. This device is the main reference for identification and traceability for MedX Health kit Item# 0910 This product is registered to show its UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
MedX Health Corp
LPS200
In Commercial Distribution

  • 00628451918196 ()
  • 00628451918349 ()


  • Musculoskeletal/physical therapy laser, professional

MedX SLD Light Cluster - 00628451918332

The MedX SLD Light diode Cluster is used together with the MedX Home console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.
MedX Health Corp
MCT1000
In Commercial Distribution

  • 00628451918332 ()
  • 00628451918172 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Home Console - 00628451918325

The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluster MCT 1000. It is the main reference for identification and traceability, and part of the kit for MedX item number #2130. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
2030
In Commercial Distribution

  • 00628451918165 ()
  • 00628451918325 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Laser Portable, tethered - 00628451918318

The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
201
In Commercial Distribution

  • 00628451918240 ()
  • 00628451918318 ()


  • Musculoskeletal/physical therapy laser, professional

MedX Rehab Tethered Laser - 00628451918301

The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116. LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
MedX Health Corp
450
In Commercial Distribution

  • 00628451918301 ()
  • 00628451918134 ()


  • Musculoskeletal/physical therapy laser, professional

LIGHTFORCE - 00190446812142

LightForce X 10W
DJO, LLC
SYS-000934-000-01
In Commercial Distribution

  • 00190446812142 ()


  • Musculoskeletal/physical therapy laser, professional

LIGHTFORCE - 00190446897842

Trade-In 600um BHP LightForce - More than 5yrs old
DJO, LLC
PRD-000424-010-01-L-G5
In Commercial Distribution

  • 00190446897842 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous

LIGHTFORCE - 00190446897910

Trade-In 800um SHP v2 Assy LightForce - less than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-L5
In Commercial Distribution

  • 00190446897910 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous

LIGHTFORCE - 00190446897903

Trade-In 800um SHP v2 Assy LightForce - more than 5 yrs old
DJO, LLC
PRD-000758-010-00-L-G5
In Commercial Distribution

  • 00190446897903 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous

LIGHTFORCE - 00190446897859

Trade-In 600um BHP LightForce - less than 5yrs old
DJO, LLC
PRD-000424-010-01-L-L5
In Commercial Distribution

  • 00190446897859 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous

LIGHTFORCE - 00190446887195

R-800um SHP v2 Assy Light Force
DJO, LLC
PRD-000758-010-00-L-R
In Commercial Distribution

  • 00190446887195 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous

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

DEKA PHYSIQ - 08057017760498

The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscles. A LED mounted on top of each handpiece is lighted when the handpiece is emitting.
EL.EN. SPA
M120F1
In Commercial Distribution

  • 08057017760498 ()
M120F1

  • Musculoskeletal infrared phototherapy unit, non-wearable

DEKA HIRO 3.0 - 08057017760214

The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG Laser source.
EL.EN. SPA
M080K1
In Commercial Distribution

  • 08057017760214 ()
M080K1

  • Musculoskeletal infrared phototherapy unit, non-wearable

SH1 - 08057017760207

The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources.
EL.EN. SPA
M077H3
In Commercial Distribution

  • 08057017760207 ()
M077H3

  • Musculoskeletal infrared phototherapy unit, non-wearable

LUMIXCPS2HP - 08057949171911

LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)
FISIOLINE SRL
LUMIX CPS
In Commercial Distribution

  • 08057949171911 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LUMIXCPS2HP

  • Skin laser scanner

LUMIX 250 - 08057949171850

LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W
FISIOLINE SRL
LUMIX 250
In Commercial Distribution

  • 08057949171850 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LUMIX250R3

  • Skin laser scanner

LUMIX 100 - 08057949171843

LASER THERAPY UNIT LUMIX 100 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 2W
FISIOLINE SRL
LUMIX 100
In Commercial Distribution

  • 08057949171843 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 20 Millimeter
LUMIX100R3

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171782

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171782 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LULTRA33HP

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171775

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171775 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LULTRA33

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171768

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171768 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LPLUS30HP

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171751

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171751 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LPLUS30

  • Skin laser scanner

LUMIX C.P.S. - 08057949171690

LASER THERAPY UNIT LUMIX C.P.S with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S. 5
In Commercial Distribution

  • 08057949171690 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
LCPS29

  • Skin laser scanner

LUMIX Q - 08057949171645

LASER THERAPY UNIT LUMIX Q with 2 WAVELENGTH (650nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S. 3
In Commercial Distribution

  • 08057949171645 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LUMIXQ01

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171638

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949171638 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1602HP

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171621

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171621 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1601HP

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171614

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910mn+1064nm)
FISIOLINE SRL
LUMIX ULTRA 1
In Commercial Distribution

  • 08057949171614 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS13HP

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171607

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949171607 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1002HP

  • Skin laser scanner

LUMIX ULTRA/PLUS - 08057949171591

LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 1
In Commercial Distribution

  • 08057949171591 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1001HP

  • Skin laser scanner
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