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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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BIO600RNIR
PLATINUM LED HOLDINGS LLC
BIO600RNIR
In Commercial Distribution

  • B842BIO600RNIR0 ()

  • 36"x9"x3"
  • 600w
  • Weight: 22 Pound
BIO600RNIR

  • Blue/red/infrared phototherapy lamp
BIO600R
PLATINUM LED HOLDINGS LLC
BIO600R
In Commercial Distribution

  • B842BIO600R0 ()

  • 600w
  • 36"x9"x3"
  • Weight: 22 Pound
BIO600R

  • Blue/red/infrared phototherapy lamp
BIO600NIR
PLATINUM LED HOLDINGS LLC
BIO600NIR
In Commercial Distribution

  • B842BIO600NIR0 ()

  • 36"x9"x3"
  • Weight: 22 Pound
  • 600w
BIO600NIR

  • Blue/red/infrared phototherapy lamp
BIO450RNIR
PLATINUM LED HOLDINGS LLC
BIO450RNIR
In Commercial Distribution

  • B842BIO450RNIR0 ()

  • 450w
  • 19"x11"x3"
  • Weight: 17 Pound
BIO450RNIR

  • Blue/red/infrared phototherapy lamp
BIO450R
PLATINUM LED HOLDINGS LLC
BIO450R
In Commercial Distribution

  • B842BIO450R0 ()

  • 450w
  • 19"x11"x3"
  • Weight: 17 Pound
BIO450R

  • Blue/red/infrared phototherapy lamp
BIO450NIR
PLATINUM LED HOLDINGS LLC
BIO450NIR
In Commercial Distribution

  • B842BIO450NIR0 ()
BIO450NIR

  • Blue/red/infrared phototherapy lamp
BIO300RNIR
PLATINUM LED HOLDINGS LLC
BIO300RNIR
In Commercial Distribution

  • B842BIO300RNIR0 ()

  • 300w
  • 19" x 9" x 3"
  • Weight: 11 Pound
BIO300RNIR

  • Blue/red/infrared phototherapy lamp
BIO300R
PLATINUM LED HOLDINGS LLC
BIO300R
In Commercial Distribution

  • B842BIO300R0 ()

  • 300w
  • 19"X9"X3"
  • Weight: 11 Pound
BIO300R

  • Blue/red/infrared phototherapy lamp
BIO300NIR
PLATINUM LED HOLDINGS LLC
BIO300NIR
In Commercial Distribution

  • B842BIO300NIR0 ()

  • 300w
  • 19"x9"x3"
  • Weight: 11 Pound
BIO300NIR

  • Blue/red/infrared phototherapy lamp
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
P4H
In Commercial Distribution

  • B679SLP4H0 ()
SLP4H

  • Musculoskeletal/physical therapy laser, professional
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