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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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An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Flash & Go FREEDOM 300K
In Commercial Distribution

  • 17290015763278 ()
  • 07290015763271 ()
  • 27290015763275 ()
7290015763271

  • Cosmetic red-light phototherapy system, home-use
An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Relief / HeatLux Pro II
In Commercial Distribution

  • 17290015418901 ()
  • 07290015418904 ()
  • 27290015418908 ()
7290015418904

  • Medium-wave diathermy treatment system generator
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Flash & Go Express
In Commercial Distribution

  • 07290015418867 ()
  • 27290015418861 ()
  • 17290015418864 ()
7290015418867

  • Cosmetic red-light phototherapy system, home-use
An over the counter phototherapy device for the treatment of mild to moderate acne.
HOME SKINOVATIONS LTD
Blue
In Commercial Distribution

  • 17290015418628 ()
  • 07290015418621 ()
  • 27290015418625 ()
7290015418621

  • Cosmetic red-light phototherapy system, home-use
An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
HOME SKINOVATIONS LTD
FaceFX II
In Commercial Distribution

  • 17290015418611 ()
  • 07290015418614 ()
  • 27290015418618 ()
7290015418614

  • Cosmetic red-light phototherapy system, home-use
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Glide 150K Brazil
In Commercial Distribution

  • 07290015418515 ()
  • 27290015418519 ()
  • 17290015418512 ()
7290015418515

  • Cosmetic red-light phototherapy system, home-use
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
HOME SKINOVATIONS LTD
Flash & Go 120K
In Commercial Distribution

  • 17290013587869 ()
  • 07290013587862 ()
  • 27290013587866 ()
7290013587862

  • Cosmetic red-light phototherapy system, home-use
The device is a face treatment device which utilizes Home Technology™. The device combines several kinds of energy: Low Level Laser Therapy (LLLT), Infrared and Bi-Polar Radio Frequency energy (Bi-Polar RF) that treat the upper layer, dermis and deep sub-dermal fat to improve the skin's appearance and reduce wrinkles. The device includes a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device is provided with an RF Attachment which provides larger treatment surface. It has a rechargeable battery for cordless use, as well as a wall adapter for connection to the mains supply.
SILKN BEAUTY LTD
Titan MultiPlatform
In Commercial Distribution

  • 27290019840231 ()
  • 17290019840234 ()
  • 07290019840237 ()
7290019840237

  • Radio-frequency skin surface treatment system applicator
LED Light Therapy Mask
SILKN BEAUTY LTD
FM-03
In Commercial Distribution

  • 27290019840057 ()
  • 17290019840050 ()
  • 07290019840053 ()
7290019840053

  • Blue/red/infrared phototherapy lamp
LED Light Therapy Mask
SILKN BEAUTY LTD
FM-02
In Commercial Distribution

  • 27290019840040 ()
  • 17290019840043 ()
  • 07290019840046 ()
7290019840046

  • Blue/red/infrared phototherapy lamp
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