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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Device indicated for 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 and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
K-Laser Cube2
In Commercial Distribution

  • B317KCUBE20 ()


  • Musculoskeletal/physical therapy laser, professional
Device indicated for 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 and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation
ELTECH KLASER SRL
K-Laser Cube
In Commercial Distribution

  • B317KCUBE0 ()


  • Musculoskeletal/physical therapy laser, professional
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
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
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
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
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
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
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
No Description
ASA SRL
F9000247
In Commercial Distribution

  • 08033765391054 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ASA SRL
Mphi D
In Commercial Distribution

  • 08033765391023 ()
F9000235

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ASA SRL
Mphi
In Commercial Distribution

  • 08033765391016 ()
F9000221

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ASA SRL
M6
In Commercial Distribution

  • 08033765391009 ()
F9000207

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
LED TECHNOLOGIES INC
TLGUM
Not in Commercial Distribution

  • B347TLGUM1 ()
  • B347TLGUM0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
TEFLEXPD
Not in Commercial Distribution

  • B347TEFLEXPD1 ()
  • B347TEFLEXPD0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
TEEYEPN
Not in Commercial Distribution

  • B347TEEYEPN1 ()
  • B347TEEYEPN0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
SPECTRAPAD
Not in Commercial Distribution

  • B347SPECTRAPAD0 ()
  • B347SPECTRAPAD1 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
RVPNSYS
Not in Commercial Distribution

  • B347RVPNSYS0 ()
  • B347RVPNSYS1 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
RVPNPAD
Not in Commercial Distribution

  • B347RVPNPAD1 ()
  • B347RVPNPAD0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
RVLBAA
Not in Commercial Distribution

  • B347RVLBAA1 ()
  • B347RVLBAA0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
RV72PNSYS
Not in Commercial Distribution

  • B347RV72PNSYS1 ()
  • B347RV72PNSYS0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
NUVEPNSYS
Not in Commercial Distribution

  • B347NUVEPNSYS1 ()
  • B347NUVEPNSYS0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
N72PNSYS
Not in Commercial Distribution

  • B347N72PNSYS1 ()
  • B347N72PNSYS0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
LTSRCE
In Commercial Distribution

  • B347LTSRCE1 ()
  • B347LTSRCE0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSNCKPW
Not in Commercial Distribution

  • B347HSNCKPW1 ()
  • B347HSNCKPW0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSKNEE
Not in Commercial Distribution

  • B347HSKNEE1 ()
  • B347HSKNEE0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSFLXWW
Not in Commercial Distribution

  • B347HSFLXWW1 ()
  • B347HSFLXWW0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSFLXPD
Not in Commercial Distribution

  • B347HSFLXPD1 ()
  • B347HSFLXPD0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSFLXMT
Not in Commercial Distribution

  • B347HSFLXMT1 ()
  • B347HSFLXMT0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HSANKLE
Not in Commercial Distribution

  • B347HSANKLE1 ()
  • B347HSANKLE0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
HANDMITT
Not in Commercial Distribution

  • B347HANDMITT1 ()
  • B347HANDMITT0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
FOOTPNSYS
Not in Commercial Distribution

  • B347FOOTPNSYS1 ()
  • B347FOOTPNSYS0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
FLJOINT
In Commercial Distribution

  • B347FLJOINT1 ()
  • B347FLJOINT0 ()
  • B347FLJOINT2 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
FLEXPADXL
Not in Commercial Distribution

  • B347FLEXPADXL1 ()
  • B347FLEXPADXL0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
FLEXPAD
In Commercial Distribution

  • B347FLEXPAD1 ()
  • B347FLEXPAD0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
F301SP
In Commercial Distribution

  • B347F301SP1 ()
  • B347F301SP0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
EMOCS
In Commercial Distribution

  • B347EMOCS0 ()
  • B347EMOCS1 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLSLIPPER
In Commercial Distribution

  • B347DPLSLIPPER1 ()
  • B347DPLSLIPPER0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLPNXL
In Commercial Distribution

  • B347DPLPNXL1 ()
  • B347DPLPNXL0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLPNSYS
In Commercial Distribution

  • B347DPLPNSYS2 ()
  • B347DPLPNSYS1 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLPNMITT
In Commercial Distribution

  • B347DPLPNMITT1 ()
  • B347DPLPNMITT0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLPADBG
Not in Commercial Distribution

  • B347DPLPADBG1 ()
  • B347DPLPADBG0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLNUVEPN
In Commercial Distribution

  • B347DPLNUVEPN1 ()
  • B347DPLNUVEPN0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLNCKPW
In Commercial Distribution

  • B347DPLNCKPW1 ()
  • B347DPLNCKPW0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLGUM
In Commercial Distribution

  • B347DPLGUM1 ()
  • B347DPLGUM0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLFLXWW
In Commercial Distribution

  • B347DPLFLXWW1 ()
  • B347DPLFLXWW0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLEYEPN
In Commercial Distribution

  • B347DPLEYEPN1 ()
  • B347DPLEYEPN0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DPLCOMWP
Not in Commercial Distribution

  • B347DPLCOMWP1 ()
  • B347DPLCOMWP0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DIYMITT
Not in Commercial Distribution

  • B347DIYMITT1 ()
  • B347DIYMITT0 ()


  • Blue/red/infrared phototherapy lamp
No Description
LED TECHNOLOGIES INC
DIYFLEX
Not in Commercial Distribution

  • B347DIYFLEX1 ()
  • B347DIYFLEX0 ()


  • Blue/red/infrared phototherapy lamp
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