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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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Amsco - 00724995153977

The AMSCO Warming Cabinet Standard Solid Dual 24-inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ040124331
In Commercial Distribution

  • 00724995153977 ()
DJ040124331

  • Multi-purpose warming cabinet, stationary
  • Multi-purpose warming cabinet, recessed

Amsco - 00724995153953

The AMSCO Warming Cabinet Standard Solid Single 24-inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ030124131
In Commercial Distribution

  • 00724995153953 ()
DJ030124131

  • Multi-purpose warming cabinet, recessed
  • Multi-purpose warming cabinet, stationary

Amsco - 00724995153946

The AMSCO Warming Cabinet Standard Solid Dual 18-inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ020124332
In Commercial Distribution

  • 00724995153946 ()
DJ020124332

  • Multi-purpose warming cabinet, recessed
  • Multi-purpose warming cabinet, stationary

Amsco - 00724995153939

The AMSCO Warming Cabinet Standard Solid Single 18inch 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ010124132
In Commercial Distribution

  • 00724995153939 ()
DJ010124132

  • Multi-purpose warming cabinet, stationary
  • Multi-purpose warming cabinet, recessed

Gemini 810+980 Diode Laser Kit, International - 00861407000389

No Description
AZENA MEDICAL, LLC
8990
Not in Commercial Distribution

  • 00861407000389 ()


  • Dental diode laser system

Epic T-Series Diode Laser System - 00647529002599

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 Refurbished
In Commercial Distribution

  • 00647529002599 ()


  • Musculoskeletal/physical therapy laser, professional

Epic S-Series Diode Laser System - 00647529002575

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

Epic T-Series Diode Laser System - 00647529000267

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

Epic S-Series Diode Laser System - 00647529000236

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

Sculpt I.Q. - D74666614201

Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420
Not in Commercial Distribution

  • D74666614201 ()
6661420

  • Dental diode laser system

Sculpt I.Q. - D74666595561

Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556
Not in Commercial Distribution

  • D74666595561 ()
6659556

  • Dental diode laser system

Sculpt I.Q. - D74666593091

MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309
Not in Commercial Distribution

  • D74666593091 ()
6659309

  • Dental diode laser system

Sculpt I.Q. - D74666592911

EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291
Not in Commercial Distribution

  • D74666592911 ()
  • D74666592910 ()
6659291

  • Dental diode laser system

Sculpt I.Q. - D74666592831

EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283
Not in Commercial Distribution

  • D74666592831 ()
  • D74666592830 ()
6659283

  • Dental diode laser system

Sculpt I.Q. - D74666592421

Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242
Not in Commercial Distribution

  • D74666592421 ()
6659242

  • Dental diode laser system

Sculpt I.Q. - D74666592341

Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234
Not in Commercial Distribution

  • D74666592341 ()
6659234

  • Dental diode laser system

Sculpt I.Q. - D74666592261

Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226
Not in Commercial Distribution

  • D74666592261 ()
6659226

  • Dental diode laser system

Sculpt I.Q. - D74666592181

Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218
Not in Commercial Distribution

  • D74666592181 ()
6659218

  • Dental diode laser system

Sculpt I.Q. - D74666592001

EasyBend - Bending tool
DENTSPLY SIRONA ORTHODONTICS INC.
6659200
Not in Commercial Distribution

  • D74666592001 ()
6659200

  • Dental diode laser system

Sculpt I.Q. - D74666591921

Optic protection cap for handpiece (5 pieces)
DENTSPLY SIRONA ORTHODONTICS INC.
6659192
Not in Commercial Distribution

  • D74666591921 ()
  • D74666591920 ()
6659192

  • Dental diode laser system

Sculpt I.Q. - D74666591841

Handpiece sleeve with keypad
DENTSPLY SIRONA ORTHODONTICS INC.
6659184
Not in Commercial Distribution

  • D74666591841 ()
6659184

  • Dental diode laser system

Sculpt I.Q. - D74666591011

Sculpt I.Q. Laser, USA
DENTSPLY SIRONA ORTHODONTICS INC.
6659101
Not in Commercial Distribution

  • D74666591011 ()
6659101

  • Dental diode laser system

OMNILUX - B434EM1387

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 - B434EM1258S0

OMNILUX MEDICAL BASE
LOTUS GLOBAL GROUP, INC, THE
EM1258S
In Commercial Distribution

  • B434EM1258S0 ()


  • Musculoskeletal/physical therapy laser, professional
  • Skin photodynamic therapy/phototherapy lamp

Therabody - 00840295401782

Hot and Heat
Therabody, Inc.
RecoveryTherm Cube
In Commercial Distribution

  • 00840295401782 ()


  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable

Sculpt I.Q. - D8076661420G1

Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420G
Not in Commercial Distribution

  • D8076661420G1 ()
6661420G

  • Dental diode laser system

Sculpt I.Q. - D8076659556G1

Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556G
Not in Commercial Distribution

  • D8076659556G1 ()
6659556G

  • Dental diode laser system

Sculpt I.Q. - D8076659309G1

MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309G
Not in Commercial Distribution

  • D8076659309G1 ()
6659309G

  • Dental diode laser system

Sculpt I.Q. - D8076659291G1

EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291G
Not in Commercial Distribution

  • D8076659291G1 ()
  • D8076659291G0 ()
6659291G

  • Dental diode laser system

Sculpt I.Q. - D8076659283G1

EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283G
Not in Commercial Distribution

  • D8076659283G1 ()
  • D8076659283G0 ()
6659283G

  • Dental diode laser system

Sculpt I.Q. - D8076659242G1

Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242G
Not in Commercial Distribution

  • D8076659242G1 ()
6659242G

  • Dental diode laser system

Sculpt I.Q. - D8076659234G1

Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234G
Not in Commercial Distribution

  • D8076659234G1 ()
6659234G

  • Dental diode laser system

Sculpt I.Q. - D8076659226G1

Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226G
Not in Commercial Distribution

  • D8076659226G1 ()
6659226G

  • Dental diode laser system

Sculpt I.Q. - D8076659218G1

Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218G
Not in Commercial Distribution

  • D8076659218G1 ()
6659218G

  • Dental diode laser system

Sculpt I.Q. - D8076659200G1

EasyBend - Bending tool
DENTSPLY SIRONA ORTHODONTICS INC.
6659200G
Not in Commercial Distribution

  • D8076659200G1 ()
6659200G

  • Dental diode laser system

Sculpt I.Q. - D8076659192G1

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

  • D8076659192G1 ()
  • D8076659192G0 ()
6659192G

  • Dental diode laser system

Sculpt I.Q. - D8076659184G1

Handpiece sleeve with keypad
DENTSPLY SIRONA ORTHODONTICS INC.
6659184G
Not in Commercial Distribution

  • D8076659184G1 ()
6659184G

  • Dental diode laser system

Sculpt I.Q. - D8076659101G1

Sculpt I.Q. Laser, USA
DENTSPLY SIRONA ORTHODONTICS INC.
6659101G
Not in Commercial Distribution

  • D8076659101G1 ()
6659101G

  • Dental diode laser system

Medmix - 08800077100045

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

Diode 755nm Alex Applicator for Soprano Titanium (Black) - 17290110123526

Diode 755nm Alex Applicator for Soprano Titanium (Black)
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110123526 ()
AASP28012401

  • Dermatological diode laser system

Soprano Titanium System 230V - 17290110121829

The Alma Lasers Soprano Titanium Laser System consists of: •System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts) •Operator control panel with touch-screen technology (GUI) •Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously Premarket Notification Traditional 510(k) Section 8: Page 2 of 4 Alma Lasers Soprano Titanium • 810 nm applicator • 755 nm applicator • Small NIR applicator • Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121829 ()
AASP05091845BSR0001

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system

Diode 3D Trio 4cm HP for Soprano Titanium - 17290110121812

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121812 ()
AASP30111208

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system

NIR Module - 17290110121676

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121676 ()
AAIR02031605

  • Multi-modality skin surface treatment system

NIR Module - 17290110121669

Nir Face (6) HP for Soprano Ice Platinum Edition\Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121669 ()
AAIR02031604

  • Multi-modality skin surface treatment system

Diode 810nm2 cm2 HP - 17290110121652

Diode 810nm Speed 2cm HP for Soprano Ice Platinum Edition / Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121652 ()
AASP30111205

  • Dermatological diode laser system

Diode Alex 755nm - 17290110121645

Diode 755nm Alex 1.5cm HP for Soprano Ice Platinum Edition/Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121645 ()
AASP02031603

  • Dermatological diode laser system

Diode 810nm 1.2 cm2 HP - 17290110121638

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121638 ()
AASP02031602

  • Dermatological diode laser system

Trio Diode Laser Module - 17290110121621

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121621 ()
AASP02031601

  • Dermatological diode laser system

Unipolar HP - 17290110121614

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121614 ()
AASR11021407

  • Radio-frequency skin/body contouring system

Bipolar HP - 17290110121607

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121607 ()
AASR11021401

  • Radio-frequency skin/body contouring system
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