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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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Portable, battery powered laser therapy device emitting up to 2W at 635nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-ProR
Not in Commercial Distribution

  • 00852116008032 ()


  • Musculoskeletal/physical therapy laser, professional
Portable, battery powered laser therapy device emitting up to 1 W at 635/808nm in CW or pulsed modes.
AVANT WELLNESS SYSTEMS INC.
LZ30-X
Not in Commercial Distribution

  • 00852116008018 ()


  • Musculoskeletal/physical therapy laser, professional
Apollo laser handheld
PIVOTAL HEALTH SOLUTIONS, INC.
Handheld, HH
In Commercial Distribution

  • 00852753008969 ()


  • Musculoskeletal/physical therapy laser, home-use
Apollo portable laser system
PIVOTAL HEALTH SOLUTIONS, INC.
Portable, AP2-PT
In Commercial Distribution

  • 00852753008891 ()


  • Musculoskeletal/physical therapy laser, home-use
Desktop laser
PIVOTAL HEALTH SOLUTIONS, INC.
Desktop AP2-DT
In Commercial Distribution

  • 00852753008884 ()


  • Musculoskeletal/physical therapy laser, professional
BDA Attachment head Flat Window
LITECURE LLC
PRD-000233-000
In Commercial Distribution

  • 00854103007349 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Large Ball
LITECURE LLC
PRD-000229-010-00
In Commercial Distribution

  • 00854103007332 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Xl Rolling Pin Attachment
LITECURE LLC
PRD-000721-000
In Commercial Distribution

  • 00854103007325 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment XL Cone
LITECURE LLC
PRD-000644-000
In Commercial Distribution

  • 00854103007318 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
Infrared phototherapy device emitting up to 10 W at 810/980 nm, 7" display
LITECURE LLC
LTC-1001-L-B6
In Commercial Distribution

  • 00854103007295 ()


  • Musculoskeletal/physical therapy laser, professional
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