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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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Mains powered, infrared phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen display. Compatible with New Empower IQ delivery system.
LITECURE LLC
LTS-2500-L-S8
In Commercial Distribution

  • 00854103007103 ()


  • Musculoskeletal/physical therapy laser, professional
Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device can be powered through its battery pack or mains power and has a 10" touch-screen display. Compatible with new empower delivery system with integrated emission control button and LED indicator.
LITECURE LLC
LTC-1510-L-B6
In Commercial Distribution

  • 00854103007097 ()


  • Musculoskeletal/physical therapy laser, professional
The LightForce XLi is a professional musculoskeletal/physical therapy laser emitting up to 40W at 810/980nm wavelengths. The LightForce XLi is indicated for emitting energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle. The XLi laser system includes a therapeutic laser console and optical delivery system. The optical delivery system consists of a flexible optical fiber connected to a hand piece with interchangeable treatment heads and provides motion feedback to the user. A custom software application allows the user to select from built-in treatment protocols that adjust dosage and wavelength based on patient characteristics and condition. The device also provides the ability to set custom treatment parameters including output power, treatment time, and pulse rate.
LITECURE LLC
LTS-4000-L
In Commercial Distribution

  • 00854103007073 ()


  • Musculoskeletal/physical therapy laser, professional
Infrared phototherapy device emitting up to 8W at 810/980nm, battery option, 10" display
LITECURE LLC
LTC-1510-SOLA
In Commercial Distribution

  • 00854103007066 ()


  • Musculoskeletal/physical therapy laser, professional
Infrared phototherapy device emitting up to 15 W at 980/810nm in CW or pulsed modes. The device can be powered through its battery pack or mains power and has a 10" touch-screen display.
LITECURE LLC
LTC-1500
In Commercial Distribution

  • 00854103007042 ()


  • Musculoskeletal/physical therapy laser, professional
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
No Description
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZLD-75W
In Commercial Distribution

  • 00850049532297 ()


  • Musculoskeletal infrared phototherapy unit, wearable
No Description
LUMITON MEDICAL PRODUCTS LLC
Cool Tangerine
In Commercial Distribution

  • 00850056402446 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
LUMITON MEDICAL PRODUCTS LLC
Fire Orange
In Commercial Distribution

  • 00850056402439 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
LUMITON MEDICAL PRODUCTS LLC
Tidal Wave
In Commercial Distribution

  • 00850056402422 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
LUMITON MEDICAL PRODUCTS LLC
Steel Grey
In Commercial Distribution

  • 00850056402415 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
LUMITON MEDICAL PRODUCTS LLC
Coral
In Commercial Distribution

  • 00850056402408 ()


  • Musculoskeletal/physical therapy laser, home-use
Collagentex Rx-3 NIR device, model Rx-3, 3 lamp module
Tanses Technologies Inc
Rx-3
In Commercial Distribution

  • 00850056256438 ()


  • Red-light phototherapy unit, professional
Collagentex Rx-2 NIR device, model Rx-2, 2 lamp module
Tanses Technologies Inc
Rx-2
In Commercial Distribution

  • 00850056256421 ()


  • Red-light phototherapy unit, professional
Collagentex Rx-1-Seat NIR device, Seat version, model Rx-1-Seat, 1 lamp module
Tanses Technologies Inc
RX-1-Seat
In Commercial Distribution

  • 00850056256414 ()


  • Red-light phototherapy unit, 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
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