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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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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

Platinum LED Therapy Lights - B842BIOMAX9000

BIOMAX900
PLATINUM LED HOLDINGS LLC
BIOMAX900
In Commercial Distribution

  • B842BIOMAX9000 ()

  • 900w
  • 36" x 12" x 3"
  • Weight: 33 Pound
BIOMAX900

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIOMAX4500

BIOMAX450
PLATINUM LED HOLDINGS LLC
BIOMAX450
In Commercial Distribution

  • B842BIOMAX4500 ()

  • 450w
  • 19" x 12" x 3"
  • Weight: 17 Pound
BIOMAX450

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO600NIR0

BIO600NIR
PLATINUM LED HOLDINGS LLC
BIO600NIR
In Commercial Distribution

  • B842BIO600NIR0 ()

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

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO450R0

BIO450R
PLATINUM LED HOLDINGS LLC
BIO450R
In Commercial Distribution

  • B842BIO450R0 ()

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

  • Blue/red/infrared phototherapy lamp

Platinum LED Therapy Lights - B842BIO300RNIR0

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

Platinum LED Therapy Lights - B842BIOMAX6000

BIOMAX600
PLATINUM LED HOLDINGS LLC
BIOMAX600
In Commercial Distribution

  • B842BIOMAX6000 ()

  • 600w
  • 36" x 9" x 3"
  • Weight: 22 Pound
BIOMAX600

  • Blue/red/infrared phototherapy lamp
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