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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BDA Attachment head Small Cone
LITECURE LLC
PRD-000232-000-L
In Commercial Distribution

  • 00854103007264 ()


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

  • 00854103007240 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment Head Large Cone
LITECURE LLC
PRD-000230-010-L
In Commercial Distribution

  • 00854103007219 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
Mains powered, Infrared phototherapy device emitting up to 15 W at 810 & 980 nm. The LightForce EX (LTS-1500) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. The EX is a portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTS-1500
In Commercial Distribution

  • 00854103007028 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Infrared phototherapy device emitting up to 15 W at 980 & 810 nm. The device can be powered through its battery pack or mains power. The LightForce FX (LTC-1500) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting. relaxation of the muscle tissue and to temporarily increase local blood circulation. The FX is a compact, portable, and mobile medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTC-1500
In Commercial Distribution

  • 00854103007011 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Mains powered, infrared phototherapy device emitting up to 9 W at 980 nm. The LightForce PRO (LTC-900) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting. relaxation of the muscle tissue and to temporarily increase local blood circulation. The PRO is a compact, portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTC-900
In Commercial Distribution

  • 00854103007004 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Joovv Go NIR is a rechargeable, battery powered infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-012850000
Not in Commercial Distribution

  • 10855501008225 ()
  • 00855501008228 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Joovv Solo is a red/infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-150660850
Not in Commercial Distribution

  • 10855501008010 ()
  • 00855501008013 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Joovv Mini is a red/infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-060660850
Not in Commercial Distribution

  • 00855501008006 ()
  • 10855501008003 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Fingertip Pulse Oximeter
Caring Mill
MD300C29
In Commercial Distribution

  • 00854875008209 ()
  • 10854875008206 ()


  • Pulse oximeter, line-powered
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
BDA Attachment Head Large Cone
LITECURE LLC
PRD-000230-000-L
In Commercial Distribution

  • 00854103007288 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Large Ball
LITECURE LLC
PRD-000229-000-L
In Commercial Distribution

  • 00854103007271 ()


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

  • 00854103007257 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Flat Window
LITECURE LLC
PRD-000233-000-L
In Commercial Distribution

  • 00854103007233 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Small Ball
LITECURE LLC
PRD-000231-000-L
In Commercial Distribution

  • 00854103007226 ()


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

  • 00854103007202 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
No Description
IHEALTH LAB INC.
PO3
In Commercial Distribution

  • 10855111003276 ()
  • 00855111003279 ()
  • 20855111003273 ()


  • Pulse oximeter
No Description
Multi Radiance Medical
PainCure
In Commercial Distribution

  • 00852556007381 ()
800-301

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
SportLaser
In Commercial Distribution

  • 00852556007374 ()
800-302

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
Gameday Laser
In Commercial Distribution

  • 00852556007367 ()
U600-220

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
Gameday Laser
In Commercial Distribution

  • 00852556007350 ()
U800-200

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
PainAway Home Care
In Commercial Distribution

  • 00852556007343 ()
600-204

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
PainAway
In Commercial Distribution

  • 00852556007336 ()
600-200

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR5 Activ Pro LaserStim G
In Commercial Distribution

  • 00852556007329 ()
U600-408G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR5 Activ Pro G
In Commercial Distribution

  • 00852556007312 ()
U600-400G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR5 Activ Pro Laser Shower G
In Commercial Distribution

  • 00852556007305 ()
U600-500G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
PainAway
In Commercial Distribution

  • 00852556007299 ()
U800-100

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
PainAway Homecare
In Commercial Distribution

  • 00852556007282 ()
U800-305

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR5 Activ Pro Laser Shower
In Commercial Distribution

  • 00852556007275 ()
U600-500

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TQ Solo Laser
In Commercial Distribution

  • 00852556007268 ()
U800-300K

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR5 Activ Pro LaserStim
In Commercial Distribution

  • 00852556007251 ()
U600-408

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR5 Activ Pro
In Commercial Distribution

  • 00852556007244 ()
U600-400

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR4 LaserShower 50 4-D Emitter G
In Commercial Distribution

  • 00852556007220 ()
650-114G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR4 Super Pulsed Laser Console G
In Commercial Distribution

  • 00852556007206 ()
600G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
Gameday Laser G
In Commercial Distribution

  • 00852556007190 ()
U300-200G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR4 Activ G
In Commercial Distribution

  • 00852556007183 ()
U600-300G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR4 Laser System G
In Commercial Distribution

  • 00852556007176 ()
U600G

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TruDenta Laser System
In Commercial Distribution

  • 00852556007169 ()
U801

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TQ LaserShower 50 4-D Emitter
In Commercial Distribution

  • 00852556007152 ()
850-114

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TQ SE25 Standard Emitter
In Commercial Distribution

  • 00852556007145 ()
850-113

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TerraQuant Super Pulsed Laser Console
In Commercial Distribution

  • 00852556007121 ()
800

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TerraQuant Laser System
In Commercial Distribution

  • 00852556007114 ()
U800

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
Gameday Laser
In Commercial Distribution

  • 00852556007107 ()
U300-200

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
PainAway PostOp Laser
In Commercial Distribution

  • 00852556007091 ()
U300-110

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
TQ Solo Laser
In Commercial Distribution

  • 00852556007084 ()
U800-300

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Multi Radiance Medical
MR4 Activ
In Commercial Distribution

  • 00852556007077 ()
U600-300

  • Musculoskeletal infrared phototherapy unit, non-wearable
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