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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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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
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
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
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