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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
Bion Enterprises, Ltd.
EC-4412
In Commercial Distribution

  • B110EC44120 ()
EC-4412

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, reagent
No Description
QUANTA SYSTEM SPA
OAM001958
In Commercial Distribution

  • 08059173396405 ()


  • Light-energy skin surface treatment system applicator
No Description
QUANTA SYSTEM SPA
OAM001957
In Commercial Distribution

  • 08059173396399 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 650 nm 48x13 (cooled)
QUANTA SYSTEM SPA
OAM001838.01
In Commercial Distribution

  • 08059173391875 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 625 nm 48x13 (cooled)
QUANTA SYSTEM SPA
OAM001836.01
In Commercial Distribution

  • 08059173391868 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 590 nm 48x13 (cooled)
QUANTA SYSTEM SPA
OAM001834.01
In Commercial Distribution

  • 08059173391851 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 570 nm 48x13 (cooled)
QUANTA SYSTEM SPA
OAM001832.01
In Commercial Distribution

  • 08059173391844 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 550 nm 48x13 (cooled)
QUANTA SYSTEM SPA
OAM001830.01
In Commercial Distribution

  • 08059173391837 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 400 nm 48x13 (cooled)
QUANTA SYSTEM SPA
OAM001828.01
In Commercial Distribution

  • 08059173391820 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 650 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002028
In Commercial Distribution

  • 08059173390236 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 625 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002027
In Commercial Distribution

  • 08059173390229 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 590 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002026
In Commercial Distribution

  • 08059173390212 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 570 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002025
In Commercial Distribution

  • 08059173390205 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 550 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002024
In Commercial Distribution

  • 08059173390199 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 400 nm 48x13 (cooled) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002023
In Commercial Distribution

  • 08059173390182 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 650 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002021
In Commercial Distribution

  • 08059173390175 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 625 nm 25x13 (for Discohttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#very Pico family)
QUANTA SYSTEM SPA
OAM002020
In Commercial Distribution

  • 08059173390168 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 625 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002019
In Commercial Distribution

  • 08059173390151 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 590 nm 25x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002018
In Commercial Distribution

  • 08059173390144 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 590 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002017
In Commercial Distribution

  • 08059173390137 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 570 nm 25x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002016
In Commercial Distribution

  • 08059173390120 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 570 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002015
In Commercial Distribution

  • 08059173390113 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 550 nm 25x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002014
In Commercial Distribution

  • 08059173390106 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 550 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002013
In Commercial Distribution

  • 08059173390090 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 400 nm 25x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002012
In Commercial Distribution

  • 08059173390083 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece 400 nm 48x13 (for Discovery Pico family)
QUANTA SYSTEM SPA
OAM002011
In Commercial Distribution

  • 08059173390076 ()


  • Light-energy skin surface treatment system applicator
Intense Pulsed Light handpiece (Removable waveguide) for Discovery Pico family
QUANTA SYSTEM SPA
OAM002010
In Commercial Distribution

  • 08059173390069 ()


  • Light-energy skin surface treatment system applicator
IPL applicator indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
VENUS CONCEPT LTD
AS120059
In Commercial Distribution

  • 07290016540444 ()
  • 07290016540550 ()


  • Light-energy skin surface treatment system applicator
IPL applicator indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
VENUS CONCEPT LTD
AS120030
In Commercial Distribution

  • 07290016540536 ()
  • 07290016540420 ()


  • Light-energy skin surface treatment system applicator
IPL applicator. Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules. Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations
VENUS CONCEPT LTD
AS120032
In Commercial Distribution

  • 07290016540406 ()
  • 07290016540512 ()


  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light ) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Pigmented lesions and removal of unwanted hair
FORMATK SYSTEMS LTD
FS90015
In Commercial Distribution

  • 07290016681390 ()
FS90015

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Pigmented lesions, Cutaneous lesions and Vascular lesions
FORMATK SYSTEMS LTD
FS90014
In Commercial Distribution

  • 07290016681383 ()
FS90014

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Reduction of unwanted hair, Pigmented lesions and Vascular lesions
FORMATK SYSTEMS LTD
FS90013
In Commercial Distribution

  • 07290016681376 ()
FS90013

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Acne, Pigmented Lesions and Vascular lesions
FORMATK SYSTEMS LTD
FS90012
In Commercial Distribution

  • 07290016681369 ()
FS90012

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Acne
FORMATK SYSTEMS LTD
FS90011
In Commercial Distribution

  • 07290016681352 ()
FS90011

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Pigmented Lesion treatments
FORMATK SYSTEMS LTD
FS60001
In Commercial Distribution

  • 07290016681307 ()
FS60001

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
FORMATK SYSTEMS LTD
FS60003
In Commercial Distribution

  • 07290016681291 ()
FS60003

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
FORMATK SYSTEMS LTD
FS60002
In Commercial Distribution

  • 07290016681284 ()
FS60002

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Pigmented Lesion treatments
FORMATK SYSTEMS LTD
FS10008
In Commercial Distribution

  • 07290016681260 ()
FS10008

  • Light-energy skin surface treatment system applicator
IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for Hair Removal treatments
FORMATK SYSTEMS LTD
FS10007
In Commercial Distribution

  • 07290016681253 ()
FS10007

  • Light-energy skin surface treatment system applicator
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