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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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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
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
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
Neutral Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
1291H
In Commercial Distribution

  • 35060441919992 ()
  • 15060441919998 ()
M004N0011

  • Electrosurgical return electrode, single-use
Neutral Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
1288H
In Commercial Distribution

  • 35060441919626 ()
  • 15060441919622 ()
  • 55060441919620 ()
6000847N

  • Electrosurgical return electrode, single-use
Neutral Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
1286H
In Commercial Distribution

  • 35060441919619 ()
  • 15060441919615 ()
  • 55060441919613 ()
6000846N

  • Electrosurgical return electrode, single-use
Neutral Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
1285H
In Commercial Distribution

  • 35060441919602 ()
  • 15060441919608 ()
  • 55060441919606 ()
6000845N

  • Electrosurgical return electrode, single-use
Neutral Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
1283H
In Commercial Distribution

  • 35060441919596 ()
  • 15060441919592 ()
  • 55060441919590 ()
  • 05060441919595 ()
6000810N

  • Electrosurgical return electrode, single-use
Neutral Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
1283H
In Commercial Distribution

  • 35060441919589 ()
  • 15060441919585 ()
  • 55060441919583 ()
6000809N

  • Electrosurgical return electrode, single-use
Neutral Electrode
NISSHA MEDICAL TECHNOLOGIES LTD
1280H
In Commercial Distribution

  • 35060441919572 ()
  • 15060441919578 ()
  • 55060441919576 ()
  • 05060441919571 ()
6000808N

  • Electrosurgical return electrode, single-use
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