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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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
No Description
QUANTA SYSTEM SPA
EAM001274
Not in Commercial Distribution

  • 08033945934767 ()


  • Multi-modality skin surface treatment system generator
No Description
QUANTA SYSTEM SPA
PZMS00013
Not in Commercial Distribution

  • 08033945934750 ()


  • Multi-modality skin surface treatment system generator
No Description
QUANTA SYSTEM SPA
PZMS00012
Not in Commercial Distribution

  • 08033945934668 ()


  • Multi-modality skin surface treatment system generator
No Description
QUANTA SYSTEM SPA
PZMS00011
Not in Commercial Distribution

  • 08033945934651 ()


  • Multi-modality skin surface treatment system generator
1540 HANDPIECE ICON, REMANUFACTURED
Cynosure, LLC
2520D-1540R
In Commercial Distribution

  • 00841494102272 ()


  • Multi-modality skin surface treatment system generator
ASSY, 1540 HANDPIECE, ICON
Cynosure, LLC
2520D-1540
In Commercial Distribution

  • 00841494100520 ()


  • Multi-modality skin surface treatment system generator
ICON CONTROL MODULE REMAN
Cynosure, LLC
2520-0003R
In Commercial Distribution

  • 00841494103774 ()


  • Multi-modality skin surface treatment system generator
Medical Aesthetic Laser for skin resurfacing
AEROLASE CORPORATION
ErbiumXL
Not in Commercial Distribution

  • 08631720003020 ()
LightPod Era

  • Multi-modality skin surface treatment system generator
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
No Description
GTG Wellness Co., Ltd.
SNOR STOP PLUS Fullset
Not in Commercial Distribution

  • 08809520341707 ()


  • Ultraviolet phototherapy unit, professional
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
M18-4300-000
In Commercial Distribution

  • 04058784002624 ()


  • Multi-modality skin surface treatment system generator
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
M18-4200-000
In Commercial Distribution

  • 04058784002617 ()


  • Multi-modality skin surface treatment system generator
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
1821
In Commercial Distribution

  • 04058784000088 ()


  • Multi-modality skin surface treatment system generator
Dermatological Er:YAG laser with 2940 nm wavelength. Intended for coagulation, vaporization, ablation and cutting of soft tissue (skin).
Asclepion Laser Technologies GmbH
1823
In Commercial Distribution

  • 04058784000224 ()


  • Multi-modality skin surface treatment system generator
No Description
Strata Skin Sciences, Inc.
100-120 Vac Non Credit
In Commercial Distribution

  • 00408919 ()


  • Ultraviolet phototherapy unit, professional
No Description
Strata Skin Sciences, Inc.
100-120 Vac Credit
In Commercial Distribution

  • 00408939 ()


  • Ultraviolet phototherapy unit, professional
Lumipulse G B-Amyloid Controls (Plasma)-N
FUJIREBIO INC.
235485
Not in Commercial Distribution

  • 04987270235485 ()

  • 4 bottles per unit; 1.0mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Lumipulse G B-Amyloid 1-42-N Plasma Calibrator
FUJIREBIO INC.
235454
In Commercial Distribution

  • 04987270235454 ()

  • 4 Bottles per unit; 1.5mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
PPHF UVA/NBUVB CL6/4L MM
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182931050 ()


  • Ultraviolet phototherapy unit, professional
PPHF COMBO 6/4L MM
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182931043 ()


  • Ultraviolet phototherapy unit, professional
PPHF UVA/NBUVB CL 6/4L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182931036 ()


  • Ultraviolet phototherapy unit, professional
PPHF UVA CL 10L MM
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182931029 ()


  • Ultraviolet phototherapy unit, professional
PPHF UVA 10L MM
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182931012 ()


  • Ultraviolet phototherapy unit, professional
PPHF UVA CL 10L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182931005 ()


  • Ultraviolet phototherapy unit, professional
PPHF NBUVB CL10L MM
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182930992 ()


  • Ultraviolet phototherapy unit, professional
PPHF NBUVB 10L MM
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182930985 ()


  • Ultraviolet phototherapy unit, professional
PPHF NBUVB CL 10L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182930978 ()


  • Ultraviolet phototherapy unit, professional
PP4800UVA/NBUVB CL24/24L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930961 ()


  • Ultraviolet phototherapy unit, professional
PP4800 UVA CL 48L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930954 ()


  • Ultraviolet phototherapy unit, professional
PP4800 NBUVB CL 48L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930947 ()


  • Ultraviolet phototherapy unit, professional
PP4000XL COMBO PC 20/20L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930930 ()


  • Ultraviolet phototherapy unit, professional
PP4000XL NBUVB PC 40L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930923 ()


  • Ultraviolet phototherapy unit, professional
PP4800 UVA PC 48L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930916 ()


  • Ultraviolet phototherapy unit, professional
PP4800UVA/NBUVB PC24/24L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930909 ()


  • Ultraviolet phototherapy unit, professional
PP4800 NBUVB PC 48L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930893 ()


  • Ultraviolet phototherapy unit, professional
PP4000UVA/NBUVB CL20/20L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000
In Commercial Distribution

  • 00810182930886 ()


  • Ultraviolet phototherapy unit, professional
PP4000 UVA CL 40L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000
In Commercial Distribution

  • 00810182930879 ()


  • Ultraviolet phototherapy unit, professional
PP4000 NBUVB CL 40L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000
In Commercial Distribution

  • 00810182930862 ()


  • Ultraviolet phototherapy unit, professional
PP4000XLCOMBO CL20/20L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930855 ()


  • Ultraviolet phototherapy unit, professional
PP4000XL NBUVB CL 40L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930848 ()


  • Ultraviolet phototherapy unit, professional
PP4000XL COMBO PC20/20L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930831 ()


  • Ultraviolet phototherapy unit, professional
PP4000XL NBUVB PC 40L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930824 ()


  • Ultraviolet phototherapy unit, professional
PP4800 UVA PC 48L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930817 ()


  • Ultraviolet phototherapy unit, professional
PP4800 COMBO PC24/24L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930800 ()


  • Ultraviolet phototherapy unit, professional
PP4800 NBUVB PC 48L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930794 ()


  • Ultraviolet phototherapy unit, professional
PP4000XL COMBO CL20/20L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930787 ()


  • Ultraviolet phototherapy unit, professional
PP4000XL NBUVB CL 40L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4000 XL
In Commercial Distribution

  • 00810182930770 ()


  • Ultraviolet phototherapy unit, professional
PP4800 COMBO CL24/24L
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro 4800 Max
In Commercial Distribution

  • 00810182930763 ()


  • Ultraviolet phototherapy unit, professional
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