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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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LUMIX 2 - 08057949170013

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

  • 08057949170013 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
L2PC01

  • Skin laser scanner

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 - 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 C.P.S. - 08057949170105

LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+980nm)
FISIOLINE SRL
LUMIX C.P.S.2
In Commercial Distribution

  • 08057949170105 ()

  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS901

  • Skin laser scanner

LUMIX C.P.S. - 08057949170075

LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.5
In Commercial Distribution

  • 08057949170075 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LCPS6

  • Skin laser scanner

LUMIX 250 - 08057949170044

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

  • 08057949170044 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LUMIX250R2

  • Skin laser scanner

LUMIX 2 - 08057949170020

LASER THERAPY UNIT LUMIX 2 with 2 WAVELENGTH
FISIOLINE SRL
LUMIX 2
In Commercial Distribution

  • 08057949170020 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
L2PC02

  • Skin laser scanner

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

INFRABALDAN - 08053782383313

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

  • 08053782383313 ()


  • Red/infrared light phototherapy unit

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

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

Phoenix Thera-Lase system - 00086001232503

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

  • 00086001232503 ()


  • Musculoskeletal/physical therapy laser, professional

528i - G6815L21000

5i Series Infrared (975nm) and Red (638nm) Laser Module
528 Innovations LLC
5i Series 975nm Laser Module
In Commercial Distribution

  • G6815L21000 ()
5L2100

  • Musculoskeletal/physical therapy laser, home-use

528i - G6815L11000

5i Series Infrared (808nm) and Red (638nm) Laser Module
528 Innovations LLC
5i Series 808nm Laser Module
In Commercial Distribution

  • G6815L11000 ()
5L1100

  • Musculoskeletal/physical therapy laser, home-use

528i - G6815H11000

5i Series Laser Therapy Handset (device) with bluetooth connectivity and user interface
528 Innovations LLC
5i Series Laser Therapy Handset
In Commercial Distribution

  • G6815H11000 ()
5H1100

  • Musculoskeletal/physical therapy laser, home-use

528i - G6815B11000

5i Series Rechargeable battery
528 Innovations LLC
5i Series Rechargeable Battery
In Commercial Distribution

  • G6815B11000 ()
5B1100

  • Musculoskeletal/physical therapy laser, home-use

OptonPro 25W - 04053815980254

No Description
Zimmer MedizinSysteme GmbH
4687
In Commercial Distribution

  • 04053815980254 ()
4687

  • Musculoskeletal/physical therapy laser, professional

Endolaser HP - 04053815088325

No Description
Zimmer MedizinSysteme GmbH
1636931
In Commercial Distribution

  • 04053815088325 ()
4697

  • Musculoskeletal/physical therapy laser, professional

OptonPro - 04053815053972

No Description
Zimmer MedizinSysteme GmbH
4682
In Commercial Distribution

  • 04053815053972 ()
4682

  • Musculoskeletal/physical therapy laser, professional

Benilight - 08809922440060

This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
Life Beam
In Commercial Distribution

  • 08809922440060 ()


  • Red/infrared light phototherapy unit

Benilight - 08809922440053

This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED-Pro Mini
In Commercial Distribution

  • 08809922440053 ()


  • Red/infrared light phototherapy unit

Benilight - 08809922440046

This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red) and 850nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED
In Commercial Distribution

  • 08809922440046 ()


  • Red/infrared light phototherapy unit

Benilight - 08809922440039

This device is an LED phototherapy unit that is used to relieve or reduce muscle pain by illuminating infrared ray. This device comprises a controller, an LED pad, an adapter and a band. The controller is connected to the LED pad that runs for 5 minutes, 15 minutes, or 30 minutes, for LO or HI, for 500Hz, 100Hz, 40Hz, 10Hz, or 2.5Hz. The wavelengths of the unit include 660nm (red), 850nm (NIR), and 940nm (NIR). The LED pad receives electrical signals from the controller and generates red and near-infrared light.
Benilight
iLED-Pro
In Commercial Distribution

  • 08809922440039 ()


  • Red/infrared light phototherapy unit

TOUCHBEAUTY - 06971024921265

Eyes beauty device
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1980K
In Commercial Distribution

  • 06971024921265 ()


  • Blue/red/infrared phototherapy lamp

TOUCHBEAUTY - 06971024921135

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1611B
In Commercial Distribution

  • 06971024921135 ()


  • Blue/red/infrared phototherapy lamp

TOUCHBEAUTY - 06971024921258

Portable LED facial device
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1696B
In Commercial Distribution

  • 06971024921258 ()


  • Blue/red/infrared phototherapy lamp

TOUCHBEAUTY - 06971024921241

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1696A
In Commercial Distribution

  • 06971024921241 ()


  • Blue/red/infrared phototherapy lamp

Touch beauty - 06971024921128

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1611A
In Commercial Distribution

  • 06971024921128 ()


  • Blue/red/infrared phototherapy lamp

Touchbeauty - 06971024920008

No Description
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD
TB-1767
In Commercial Distribution

  • 06971024920008 ()


  • Blue/red/infrared phototherapy lamp

Laserconn - 06972558160021

Diode laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, temporary increase local blood circulation and promoting relaxation of muscle
Sanhe Laserconn Tech Co., Ltd.
Theralas
In Commercial Distribution

  • 16972558160028 ()
  • 06972558160021 ()

  • Length: 462.50 Micrometer
  • Width: 368.00 Micrometer
  • Height: 264.58 Micrometer
Laser Therapy System

  • Musculoskeletal/physical therapy laser, professional

ideainfrared - 06974958310082

LED Red Therapy Light
Shenzhen Idea Light Limited
RL60S
In Commercial Distribution

  • 06974958310082 ()


  • Red/infrared light phototherapy unit
  • Cosmetic red-light phototherapy system, home-use

ideainfrared - 06974958310044

Portable red light therapy
Shenzhen Idea Light Limited
RTL12C
In Commercial Distribution

  • 06974958310044 ()


  • Red/infrared light phototherapy unit
  • Cosmetic red-light phototherapy system, home-use

Dimed - 06974214160192

Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
Wuhan Dimed Laser Technology Co., Ltd.
CHERYLAS-20N
In Commercial Distribution

  • 06974214160192 ()


  • Musculoskeletal/physical therapy laser, professional

Dimed - 06974214160185

Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
Wuhan Dimed Laser Technology Co., Ltd.
CHERYLAS-15N
In Commercial Distribution

  • 06974214160185 ()


  • Musculoskeletal/physical therapy laser, professional

Dimed - 06974214160178

Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
Wuhan Dimed Laser Technology Co., Ltd.
CHERYLAS-60K
In Commercial Distribution

  • 06974214160178 ()


  • Musculoskeletal/physical therapy laser, professional

Dimed - 06974214160161

Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
Wuhan Dimed Laser Technology Co., Ltd.
CHERYLAS-70J
In Commercial Distribution

  • 06974214160161 ()


  • Musculoskeletal/physical therapy laser, professional

Dimed - 06974214160154

Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
Wuhan Dimed Laser Technology Co., Ltd.
CHERYLAS-60J
In Commercial Distribution

  • 06974214160154 ()


  • Musculoskeletal/physical therapy laser, professional
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