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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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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

Regenalase - 00810071230530

Laser System
IPG Medical Corporation
MD2300F-001534
In Commercial Distribution

  • 00810071230530 ()


  • General/multiple surgical diode laser system
  • Musculoskeletal/physical therapy laser, professional

Regenalase - 00810071230516

Regenalase Therapy Kit, Regenalase Photobiomodulation (PBM) Kit
IPG Medical Corporation
MD2300F-001518
In Commercial Distribution

  • 00810071230516 ()


  • General/multiple surgical diode laser system
  • Musculoskeletal/physical therapy laser, professional

Regenalase - 00810071230509

Laser System
IPG Medical Corporation
MD2300F-001780
In Commercial Distribution

  • 00810071230509 ()


  • General/multiple surgical diode laser system
  • Musculoskeletal/physical therapy laser, professional

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
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