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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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Enhanced AURORA™ Medical Diode System, and related accessories - B780AUR20000

The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
PSORIA-SHIELD INC.
2000
In Commercial Distribution

  • B780AUR20000 ()


  • Ultraviolet phototherapy unit, professional

Quantabella - 08033945934767

No Description
QUANTA SYSTEM SPA
EAM001274
Not in Commercial Distribution

  • 08033945934767 ()


  • Multi-modality skin surface treatment system generator

Quanta forte - 08033945934750

No Description
QUANTA SYSTEM SPA
PZMS00013
Not in Commercial Distribution

  • 08033945934750 ()


  • Multi-modality skin surface treatment system generator

Quanta forte - 08033945934668

No Description
QUANTA SYSTEM SPA
PZMS00012
Not in Commercial Distribution

  • 08033945934668 ()


  • Multi-modality skin surface treatment system generator

Quanta forte - 08033945934651

No Description
QUANTA SYSTEM SPA
PZMS00011
Not in Commercial Distribution

  • 08033945934651 ()


  • Multi-modality skin surface treatment system generator

Aerolase - 08631720003020

Medical Aesthetic Laser for skin resurfacing
AEROLASE CORPORATION
ErbiumXL
Not in Commercial Distribution

  • 08631720003020 ()
LightPod Era

  • Multi-modality skin surface treatment system generator

ASSY, 1540 HANDPIECE, ICON - 00841494100520

ASSY, 1540 HANDPIECE, ICON
Cynosure, LLC
2520D-1540
In Commercial Distribution

  • 00841494100520 ()


  • Multi-modality skin surface treatment system generator

ICON CONTROL MODULE REMAN - 00841494103774

ICON CONTROL MODULE REMAN
Cynosure, LLC
2520-0003R
In Commercial Distribution

  • 00841494103774 ()


  • Multi-modality skin surface treatment system generator

1540 HANDPIECE ICON, REMANUFACTURED - 00841494102272

1540 HANDPIECE ICON, REMANUFACTURED
Cynosure, LLC
2520D-1540R
In Commercial Distribution

  • 00841494102272 ()


  • Multi-modality skin surface treatment system generator

Exciplex® - 03760313461000

Exciplex® set - USA This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.
CLARTEIS
EIPL-100
In Commercial Distribution

  • 03760313461000 ()
EIPL-PRD-K01-(US)

  • Ultraviolet phototherapy unit, professional
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