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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LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 1
In Commercial Distribution

  • 08057949171577 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
LULTRA21HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949171560 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LULTRA1902HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) version HP
FISIOLINE SRL
LUMIX ULTRA 2
In Commercial Distribution

  • 08057949171553 ()

  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 20 Millimeter
LULTRA1901HP

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949170402 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1602

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949170372 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LPLUS1002

  • Skin laser scanner
LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
FISIOLINE SRL
LUMIX ULTRA 1
In Commercial Distribution

  • 08057949170358 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LULTRA35

  • Skin laser scanner
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
FISIOLINE SRL
LUMIX ULTRA 3
In Commercial Distribution

  • 08057949170334 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LULTRA1902

  • Skin laser scanner
LASER THERAPY UNIT LUMIX CW with 3 WAVELENGTH (650nm+810nm+1064nm)
FISIOLINE SRL
LCW1402
In Commercial Distribution

  • 08057949170280 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 1064 Nanometer


  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.3
In Commercial Distribution

  • 08057949170167 ()

  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS31

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.5
In Commercial Distribution

  • 08057949170143 ()

  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS1502

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+980nm)
FISIOLINE SRL
LUMIX C.P.S.4
In Commercial Distribution

  • 08057949170136 ()

  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS1501

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.3
In Commercial Distribution

  • 08057949170129 ()

  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS12

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.3
In Commercial Distribution

  • 08057949170112 ()

  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS902

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+980nm)
FISIOLINE SRL
LUMIX C.P.S.2
In Commercial Distribution

  • 08057949170105 ()

  • Lumen/Inner Diameter: 980 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS901

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+810nm+910nm)
FISIOLINE SRL
LUMIX C.P.S.1
In Commercial Distribution

  • 08057949170099 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
LCPS702

  • Skin laser scanner
LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm)
FISIOLINE SRL
LUMIX C.P.S.5
In Commercial Distribution

  • 08057949170075 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 1064 Nanometer
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 810 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LCPS6

  • Skin laser scanner
LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W
FISIOLINE SRL
LUMIX 250
In Commercial Distribution

  • 08057949170044 ()

  • Lumen/Inner Diameter: 20 Millimeter
  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
LUMIX250R2

  • Skin laser scanner
LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm)
FISIOLINE SRL
LUMIX 2
In Commercial Distribution

  • 08057949170013 ()

  • Lumen/Inner Diameter: 910 Nanometer
  • Lumen/Inner Diameter: 650 Nanometer
  • Lumen/Inner Diameter: 10 Millimeter
L2PC01

  • Skin laser scanner
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
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
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
5i Series Rechargeable battery
528 Innovations LLC
5i Series Rechargeable Battery
In Commercial Distribution

  • G6815B11000 ()
5B1100

  • Musculoskeletal/physical therapy laser, home-use
No Description
ULTRALITE ENTERPRISES INC
72P12VB
In Commercial Distribution

  • B27672P12VB0 ()


  • Ultraviolet phototherapy unit, home-use
No Description
ULTRALITE ENTERPRISES INC
72P08NB
In Commercial Distribution

  • B27672P08NB0 ()


  • Ultraviolet phototherapy unit, home-use
No Description
Meditech International Inc
SLD+ 180
In Commercial Distribution

  • B271SLD1800 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
SLD+ 120
In Commercial Distribution

  • B271SLD1200 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
MCU IV
In Commercial Distribution

  • B271MCUIV0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
MCU III
In Commercial Distribution

  • B271MCUIII0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
MCU I
In Commercial Distribution

  • B271MCUI0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 4890
In Commercial Distribution

  • B271LSB48900 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 3270
In Commercial Distribution

  • B271LSB32700 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 3000+
In Commercial Distribution

  • B271LSB3000P0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 2250+
In Commercial Distribution

  • B271LSB2250P0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LD-R 100+
In Commercial Distribution

  • B271LDR100P0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LD-R 100
In Commercial Distribution

  • B271LDR1000 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 3000
In Commercial Distribution

  • B271DUO2400 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
LS-B 2250
In Commercial Distribution

  • B271DUO1800 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
CU+A
In Commercial Distribution

  • B271CUPA0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
CU+
In Commercial Distribution

  • B271CUP0 ()


  • Red-light phototherapy unit, professional
No Description
Meditech International Inc
CU
In Commercial Distribution

  • B271CU0 ()


  • Red-light phototherapy unit, professional
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