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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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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

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
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