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

  • 06974214160017 ()


  • Musculoskeletal/physical therapy laser, professional
Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K)
Wuhan Dimed Laser Technology Co., Ltd.
BERYLAS-15FJ
In Commercial Distribution

  • 06974214160000 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
Hunan Ruijiu Technology Co., Ltd.
RedX N1
In Commercial Distribution

  • 06976510830083 ()


  • Multi-modality physical therapy system, professional-use
No Description
Hunan Ruijiu Technology Co., Ltd.
RLT300
In Commercial Distribution

  • 06976510830076 ()


  • Multi-modality physical therapy system, professional-use
RL-100
Hunan Ruijiu Technology Co., Ltd.
RL-100
In Commercial Distribution

  • 06976510830038 ()


  • Multi-modality physical therapy system, professional-use
Infrared and near infrared phototherapy device emitting up to 30 W at 810nm, 915nm, 940nm, 980nm, 650nm, 10.1 Inch LCD Touch Screen display
Fotonmedix Medical Laser Co., LTD
LaserMedix3000U5
In Commercial Distribution

  • 06976487170090 ()


  • Musculoskeletal/physical therapy laser, professional
Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen display
Fotonmedix Medical Laser Co., LTD
LaserMedix4500U1
In Commercial Distribution

  • 06976487170007 ()


  • Musculoskeletal/physical therapy laser, professional
ScienlodicSciContour Body/Skin, SciVive Hair+BodySciTheraRecover,BioEpicPanel,SB012SB360, led mask
Star Bio Co.,Ltd
-
In Commercial Distribution

  • 06977382490047 ()


  • Blue/red/infrared phototherapy lamp
No Description
Powermedic ApS
45156
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45155
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45151
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45056
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45055
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
45051
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
40156
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
40151
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
40056
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
40051
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35164
Not in Commercial Distribution

  • 57135920351647 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35163
Not in Commercial Distribution

  • 57135920351630 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35162
Not in Commercial Distribution

  • 57135920351623 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35154
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35153
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35152
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35124
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35123
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35122
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35054
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35053
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
35052
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30164
Not in Commercial Distribution

  • 57135920301642 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30163
Not in Commercial Distribution

  • 57135920301635 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30162
Not in Commercial Distribution

  • 57135920301628 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30154
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30153
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30152
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30124
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30123
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30122
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30054
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30053
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
30052
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, home-use
No Description
Powermedic ApS
22250
Not in Commercial Distribution



  • Musculoskeletal/physical therapy laser, professional
No Description
Cofoe Medical Technology Co.,Ltd
KF-29
Not in Commercial Distribution

  • 06950715501054 ()


  • Blue/red/infrared phototherapy lamp
Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help minor muscular back pain.
Chongqing Yuhe Medical Instruments Co., Ltd.
TDP-124D,TDP-166D
In Commercial Distribution

  • 06970567470162 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Bashan TDP Heat Lamp, including TDP-124D/166D and TDP-124F/166F, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help minor muscular back pain.
Chongqing Yuhe Medical Instruments Co., Ltd.
TDP-124F,TDP-166F
In Commercial Distribution

  • 06970567470155 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Lumaflex Panel (Model: ZLD-05) is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZLD-05
In Commercial Distribution

  • 06970006971038 ()


  • Red/infrared light phototherapy unit
The Lumaflex Panel (Model: ZLD-05A) is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. CLOSE
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZLD-05A
In Commercial Distribution

  • 06970006971649 ()


  • Red/infrared light phototherapy unit
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