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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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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
Titan S IPL Handpiece
CUTERA, INC.
Titan S
In Commercial Distribution

  • 00816722022929 ()


  • Dermatological laser beam guiding handpiece
Titan XL IPL Handpiece
CUTERA, INC.
Titan XL
In Commercial Distribution

  • 00816722022912 ()


  • Multi-modality skin contouring system applicator, infrared light
Titan V IPL Handpiece
CUTERA, INC.
Titan V
In Commercial Distribution

  • 00816722022905 ()


  • Dermatological laser beam guiding handpiece
Titan IPL Handpiece for xeo+/xeo+ SA
CUTERA, INC.
Titan
In Commercial Distribution

  • 00816722022837 ()


  • Multi-modality skin contouring system applicator, infrared light
Solera Titan IPL System
CUTERA, INC.
Solera Titan
In Commercial Distribution

  • 00816722021915 ()


  • Multi-modality skin surface treatment system
The Scalar Wave Laser System 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.
STELLAR LASERS LLC
600140
In Commercial Distribution

  • B3926001400 ()


  • Musculoskeletal/physical therapy laser, home-use
The Scalar Wave Laser System 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.
STELLAR LASERS LLC
600130
In Commercial Distribution

  • B3926001300 ()


  • Musculoskeletal/physical therapy laser, home-use
The Scalar Wave Laser System 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.
STELLAR LASERS LLC
600120
In Commercial Distribution

  • B3926001200 ()


  • Musculoskeletal/physical therapy laser, home-use
The Scalar Wave Laser System 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.
STELLAR LASERS LLC
600110
In Commercial Distribution

  • B3926001100 ()


  • Musculoskeletal/physical therapy laser, home-use
The Scalar Wave Laser System 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.
STELLAR LASERS LLC
600100
In Commercial Distribution

  • B3926001000 ()


  • Musculoskeletal/physical therapy laser, home-use
NEO PATIENT REMOTE
DJO, LLC
70008
In Commercial Distribution

  • 00888912368964 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
NEO MODULE LASER
DJO, LLC
70005
In Commercial Distribution

  • 00888912368933 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
KIT INTERLOCK LASERMOBILE/TRAN
DJO, LLC
27904K
In Commercial Distribution

  • 00888912294393 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
SERVICE PART KIT INTERLOCK EPR LASER MODULE
DJO, LLC
27900K-SP
In Commercial Distribution

  • 00888912294386 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
KIT INTERLOCK EPR LASER DOOR MODULE
DJO, LLC
27900K
In Commercial Distribution

  • 00888912294379 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
APPLICATOR SINGLE 850NM 200MW
DJO, LLC
27841
In Commercial Distribution

  • 00888912294003 ()


  • Musculoskeletal/physical therapy laser, professional
APPLICATOR SINGLE 850NM 100MW
DJO, LLC
27840
In Commercial Distribution

  • 00888912293990 ()


  • Musculoskeletal/physical therapy laser, professional
VECTRA GENISYS LASER PKG
DJO, LLC
2784
In Commercial Distribution

  • 00888912293983 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
APPLICATOR 13CLS 3X200MW 715MW
DJO, LLC
27816
In Commercial Distribution

  • 00888912293891 ()


  • Musculoskeletal/physical therapy laser, professional
APPLICATOR 19CLS LED 325MW
DJO, LLC
27815
In Commercial Distribution

  • 00888912293884 ()


  • Musculoskeletal/physical therapy laser, professional
APPLICATOR 13CLSX100MW 415MW
DJO, LLC
27814
In Commercial Distribution

  • 00888912293877 ()


  • Musculoskeletal/physical therapy laser, professional
APPLICATOR 13CLS 3X50MW 265MW
DJO, LLC
27813
In Commercial Distribution

  • 00888912293860 ()


  • Musculoskeletal/physical therapy laser, professional
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