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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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Silk'n - 17290016627135

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 International
In Commercial Distribution

  • 07290016627138 ()
  • 27290016627132 ()
  • 17290016627135 ()
7290016627138

  • Medium-wave diathermy treatment system generator

Silk'n - 17290016627128

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 Pro
In Commercial Distribution

  • 07290016627121 ()
  • 27290016627125 ()
  • 17290016627128 ()
7290016627121

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290016627081

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
BellaFlash Pro
In Commercial Distribution

  • 07290016627084 ()
  • 27290016627088 ()
  • 17290016627081 ()
7290016627084

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290015764756

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 the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of treatment regime. The electric output is indicated for facial stimulation for over-the-counter aesthetic use.
HOME SKINOVATIONS LTD
Infinity
In Commercial Distribution

  • 17290015764756 ()
  • 07290015764759 ()
  • 27290015764753 ()
7290015764759

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290015764640

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
Jewel
In Commercial Distribution

  • 07290015764643 ()
  • 27290015764647 ()
  • 17290015764640 ()
7290015764643

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290015764633

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 360
In Commercial Distribution

  • 07290015764636 ()
  • 17290015764633 ()
  • 27290015764630 ()
7290015764636

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290015764527

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
BellaGlide
In Commercial Distribution

  • 07290015764520 ()
  • 27290015764524 ()
  • 17290015764527 ()
7290015764520

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290015764039

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 Express Brazil
In Commercial Distribution

  • 07290015764032 ()
  • 27290015764036 ()
  • 17290015764039 ()
7290015764032

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290015763858

The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
Titan
In Commercial Distribution

  • 07290015763851 ()
  • 17290015763858 ()
  • 27290015763855 ()
7290015763851

  • Radio-frequency skin surface treatment system

Silk'n - 17290015763278

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

Silk'n - 17290015418901

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

Silk'n - 17290015418864

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

Silk'n - 17290015418628

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

Silk'n - 17290015418611

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

Silk'n - 17290015418512

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

Silk'n - 17290013587869

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

Silk'n - 17290019840234

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

Silk'n - 17290019840050

LED Light Therapy Mask
SILKN BEAUTY LTD
FM-03
In Commercial Distribution

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

  • Blue/red/infrared phototherapy lamp

Silk'n - 17290019840043

LED Light Therapy Mask
SILKN BEAUTY LTD
FM-02
In Commercial Distribution

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

  • Blue/red/infrared phototherapy lamp

Silk'n - 17290019840036

The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
SILKN BEAUTY LTD
BellaVisage Hybrid
In Commercial Distribution

  • 07290019840039 ()
  • 17290019840036 ()
7290019840039

  • Radio-frequency skin surface treatment system applicator

Solio - 17290017992003

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
Solio Alfa +
In Commercial Distribution

  • 07290017992006 ()
  • 17290017992003 ()
  • 27290017992000 ()
7290017992006

  • Medium-wave diathermy treatment system generator

Silk'n - 17290016627388

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
BellaGlide
In Commercial Distribution

  • 07290016627381 ()
  • 27290016627385 ()
  • 17290016627388 ()
7290016627381

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290015418468

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 Compact
In Commercial Distribution

  • 07290015418461 ()
  • 27290015418465 ()
  • 17290015418468 ()
7290015418461

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290112452013

The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
BellaVisage Hybrid
In Commercial Distribution

  • 17290112452013 ()
  • 07290112452016 ()
7290112452016

  • Radio-frequency skin surface treatment system

Silk'n - 17290112451672

ToothWave™ is a powered radiofrequency toothbrush intended to promote good oral hygiene, including reduction of plaque and the prevention and treatment of gingivitis. ToothWave™ is intended for over-the-counter use.
HOME SKINOVATIONS LTD
ToothWave US
In Commercial Distribution

  • 07290112451675 ()
  • 17290112451672 ()
  • 27290112451679 ()
7290112451675

  • Radio-frequency toothbrush

Silk'n - 17290112451559

The Silk'n Titan Allways is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n Titan Allways is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The Silk'n Titan AllWays device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
HOME SKINOVATIONS LTD
Titan AllWays
In Commercial Distribution

  • 17290112451559 ()
  • 07290112451552 ()
7290112451552

  • Radio-frequency skin surface treatment system

Silk'n - 17290112450552

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 LUXX Mini-Spa
In Commercial Distribution

  • 27290112450559 ()
  • 17290112450552 ()
  • 07290112450555 ()
7290112450555

  • Cosmetic red-light phototherapy system, home-use

Silk'n - 17290112450224

The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
HOME SKINOVATIONS LTD
BellaVisage
In Commercial Distribution

  • 17290112450224 ()
  • 07290112450227 ()
  • 27290112450221 ()
7290112450227

  • Radio-frequency skin surface treatment system

Silk'n - 17290112450064

No Description
HOME SKINOVATIONS LTD
Tightra NA
In Commercial Distribution

  • 07290112450067 ()
  • 17290112450064 ()
  • 37290112450068 ()
  • 27290112450061 ()
7290112450067

  • Penile sexual vibrator

Reveal 35C - 16280119411015

The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.
KA Imaging Inc
1
Not in Commercial Distribution

  • 16280119411015 ()
101

  • Indirect flat panel x-ray detector
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