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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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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 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
AS120031
In Commercial Distribution

  • 07290016540413 ()
  • 07290016540529 ()


  • 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
• Treatment of benign pigmented epidermal and cutaneous lesions including: dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait macules. • Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations
VENUS CONCEPT LTD
AS120033
In Commercial Distribution

  • 07290016540505 ()
  • 07290016540390 ()


  • 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
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