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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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Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics, Inc.
CL0073
In Commercial Distribution

  • 00869164000086 ()


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Patient access use to the Zerigo Home Light Therapy System, including the provision of the light-emitting device, for the treatment of chronic dermatological conditions such as Psoriasis, Vitiligo, and Eczema for a limited utilization period.
Zerigo Health, Inc.
HD-02
In Commercial Distribution

HD-02-1

  • Ultraviolet phototherapy unit, professional
The Zerigo Home Light Therapy System treats chronic dermatological diseases such as Psoriasis, Vitiligo and Eczema.
Zerigo Health, Inc.
HD-02
In Commercial Distribution

  • 00865522000415 ()
HD-02

  • Ultraviolet phototherapy unit, professional
The Clarify Home Light Therapy System treats chronic dermatological diseases such as Psoriasis, Vitiligo and Eczema.
Zerigo Health, Inc.
HD-01
In Commercial Distribution

  • 00865522000408 ()
HD-01

  • Ultraviolet phototherapy unit, professional
medical aesthetic laser for skin resurfacing
AEROLASE CORPORATION
ErbiumXL
In Commercial Distribution

  • 00863172000311 ()


  • Multi-modality skin surface treatment system generator
No Description
ROHRER AESTHETICS, LLC
Spectrum
In Commercial Distribution

  • 00860564000317 ()


  • 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
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
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)
Daeju Medi Tech Engineering
1.0
In Commercial Distribution

  • 08800017500102 ()
DJMD0004

  • Multi-modality skin surface treatment system generator
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