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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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A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.
Biolase, Inc.
7400055
In Commercial Distribution

  • 00647529000267 ()
7400055

  • Musculoskeletal/physical therapy laser, professional
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054
In Commercial Distribution

  • 00647529000236 ()
7400054

  • General/multiple surgical diode laser system
A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400054 Refurbished
In Commercial Distribution

  • 00647529002575 ()


  • General/multiple surgical diode laser system
No Description
AZENA MEDICAL, LLC
8990
Not in Commercial Distribution

  • 00861407000389 ()


  • Dental diode laser system
SMARTLUX MINI is the combination of low power beam irradiator and infrared irradiator, and it is KGMP, CE/MDD class IIa class medical equipment. Your attention to prevent danger or injury is required. Please read User’s Manual carefully before you use medical equipment, and if you have any questions on safety, application, or operation of the equipment, please contact MEDMIX Co., Ltd. or its distributor.
Medmix Co., Ltd.
D478000
Not in Commercial Distribution

  • 08800077100045 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
Hot and Heat
Therabody, Inc.
RecoveryTherm Cube
In Commercial Distribution

  • 00840295401782 ()


  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420G
Not in Commercial Distribution

  • D8076661420G1 ()
6661420G

  • Dental diode laser system
Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556G
Not in Commercial Distribution

  • D8076659556G1 ()
6659556G

  • Dental diode laser system
MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309G
Not in Commercial Distribution

  • D8076659309G1 ()
6659309G

  • Dental diode laser system
EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291G
Not in Commercial Distribution

  • D8076659291G1 ()
  • D8076659291G0 ()
6659291G

  • Dental diode laser system
EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283G
Not in Commercial Distribution

  • D8076659283G1 ()
  • D8076659283G0 ()
6659283G

  • Dental diode laser system
Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242G
Not in Commercial Distribution

  • D8076659242G1 ()
6659242G

  • Dental diode laser system
Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234G
Not in Commercial Distribution

  • D8076659234G1 ()
6659234G

  • Dental diode laser system
Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226G
Not in Commercial Distribution

  • D8076659226G1 ()
6659226G

  • Dental diode laser system
Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218G
Not in Commercial Distribution

  • D8076659218G1 ()
6659218G

  • Dental diode laser system
EasyBend - Bending tool
DENTSPLY SIRONA ORTHODONTICS INC.
6659200G
Not in Commercial Distribution

  • D8076659200G1 ()
6659200G

  • Dental diode laser system
Optic protection cap for handpiece (5 pieces)
DENTSPLY SIRONA ORTHODONTICS INC.
6659192G
Not in Commercial Distribution

  • D8076659192G1 ()
  • D8076659192G0 ()
6659192G

  • Dental diode laser system
Handpiece sleeve with keypad
DENTSPLY SIRONA ORTHODONTICS INC.
6659184G
Not in Commercial Distribution

  • D8076659184G1 ()
6659184G

  • Dental diode laser system
Sculpt I.Q. Laser, USA
DENTSPLY SIRONA ORTHODONTICS INC.
6659101G
Not in Commercial Distribution

  • D8076659101G1 ()
6659101G

  • Dental diode laser system
OMNILUX MEDICAL PLUS HEAD
LOTUS GLOBAL GROUP, INC, THE
EM1387
In Commercial Distribution

  • B434EM1387 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
OMNILUX MEDICAL BASE
LOTUS GLOBAL GROUP, INC, THE
EM1258S
In Commercial Distribution

  • B434EM1258S0 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp
Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420
Not in Commercial Distribution

  • D74666614201 ()
6661420

  • Dental diode laser system
Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556
Not in Commercial Distribution

  • D74666595561 ()
6659556

  • Dental diode laser system
MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309
Not in Commercial Distribution

  • D74666593091 ()
6659309

  • Dental diode laser system
EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291
Not in Commercial Distribution

  • D74666592911 ()
  • D74666592910 ()
6659291

  • Dental diode laser system
EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283
Not in Commercial Distribution

  • D74666592831 ()
  • D74666592830 ()
6659283

  • Dental diode laser system
Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242
Not in Commercial Distribution

  • D74666592421 ()
6659242

  • Dental diode laser system
Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234
Not in Commercial Distribution

  • D74666592341 ()
6659234

  • Dental diode laser system
Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226
Not in Commercial Distribution

  • D74666592261 ()
6659226

  • Dental diode laser system
Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218
Not in Commercial Distribution

  • D74666592181 ()
6659218

  • Dental diode laser system
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