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

  • 08631720003020 ()
LightPod Era

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

  • 00841494100520 ()


  • Multi-modality skin surface treatment system generator
Exci308® by Aerolase 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

  • 03760313461017 ()
EIPL-PRD-K01-exci308

  • Ultraviolet phototherapy unit, professional
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
PPHF UVA/NBUVB CL6/4L MM
DAAVLIN DISTRIBUTING CO., THE
Phothera Pro HF
In Commercial Distribution

  • 00810182931050 ()


  • 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
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