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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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moorVMS-PRES - Pressure Cuff Controller
MOOR INSTRUMENTS LIMITED
moorVMS-PRES
In Commercial Distribution

  • 15060484490010 ()


  • Laser Doppler blood flowmeter
moorVMS-LDF - Laser Doppler Perfusion and Temperature Monitor
MOOR INSTRUMENTS LIMITED
moorVMS-LDF
In Commercial Distribution

  • 15060484490003 ()


  • Laser Doppler blood flowmeter
NeoNavia base unit
NeoDynamics AB (publ)
1102
Not in Commercial Distribution

  • 27350081940083 ()
  • 17350081940086 ()
1102

  • Mammographic stereotactic biopsy system
NeoNavia driver
NeoDynamics AB (publ)
1103
Not in Commercial Distribution

  • 27350081940045 ()
  • 17350081940048 ()
  • 37350081940042 ()
1103

  • Mammographic stereotactic biopsy system
The DEA is intended to do the exams related to the analysis and possible diagnosis of Dry Eye Disease(DED) through the connection of the device to you pc, and particularly. • Interferometry: records a video to the patient’s eye to analyze quantitatively and qualitatively lipid layer of the tear film, to compare it with the related grading scale and save the value; • Tear Meniscus Hight: The tear secretion of the lacrimal layer was assessed by measuring the height of the tear meniscus; • NIBUT: recording a video, it allows to evaluate the stability of the tear film between the break up time in a non-invasive way and to save the value; • Fluorescein BUT: records a video for the evaluation of the tear film’s stability, but it is done with instillation of the fluorescein in the patient’s eye (invasive) and without cone; • Meibography: takes a picture of meibomian glands using infrared light. The device can analyze automatically the loss area of the glands to compare it with the related grading scale; • Additional exams: checks for Bulbar Redness, Blepharitis, Demodex, pupillometry. All the exams that can be performed with the DEA are of fundamental importance for the ophthalmologist and the optometrist (within their respective professional skins) to study the tear film and for coaching the exams done with the classic instruments (Slit Lamp, Topography, Tonometry, etc.).
Shenzhen CERTAINN Technology Co., Ltd.
DEA
In Commercial Distribution

  • 06972039971641 ()


  • Meibomian gland camera/ophthalmic interferometer
The key technique used in the easyRef Handheld Auto Refractometer is based on principle of Hartmann wave-front sensing. Light is emitted from the light source system inside the device, and then focuses on the bottom of the eye through the spectroscope and exit port, then the light is reflected back to the device, and beam through lens system and received by CCD camera. It is possible to calculate the diopter of the human eye by detecting the offset between the relative calibration light and the spot array formed by the light spot of each sub-aperture.
Shenzhen CERTAINN Technology Co., Ltd.
easyRef
In Commercial Distribution

  • 06972039971573 ()


  • Automated ophthalmic refractometer
The manual refractometer is composed of a lens and a removable eye chart. The testee is required to move the position of the eye chart after resetting to make the visual target become clearer from blur. Once the clearest position of the visual target is determined, the testee’s estimated refractive error can be read from the display screen of the instrument.
Shenzhen CERTAINN Technology Co., Ltd.
iRef
In Commercial Distribution

  • 06972039971542 ()


  • Hand-held subjective ophthalmic refractometer
The Slit Lamp comprises an illumination and a Binocular Microscope. The entire device can be moved in front of the eye using the instrument base. The illumination offers a range of setting possibilities for making the practically invisible areas of the eye visible. There is also a range of accessories available for the Slit Lamp to allow special diagnosis possibilities in addition to the general examinations. A camera may be attached to the slit lamp to take photographs of different parts of the eye.
Shenzhen CERTAINN Technology Co., Ltd.
SL-M6
In Commercial Distribution

  • 06972039971405 ()


  • Ophthalmic examination slit lamp
Apex Locator
J.MORITA MFG.CORP.
RCM-7
In Commercial Distribution

  • 00887919758013 ()
5025412U0

  • Endodontic apex locator
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 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
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
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
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
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
No Description
HOME SKINOVATIONS LTD
Tightra NA
In Commercial Distribution

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

  • Penile sexual vibrator
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
Renelif
In Commercial Distribution

  • 07290106259218 ()
  • 27290106259212 ()
  • 17290106259215 ()
7290106259218

  • 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.
SILKN BEAUTY LTD
Silk'n 7
In Commercial Distribution

  • 27290019840255 ()
  • 17290019840258 ()
  • 07290019840251 ()
7290019840251

  • 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.
SILKN BEAUTY LTD
Silk'n 7
In Commercial Distribution

  • 27290019840248 ()
  • 17290019840241 ()
  • 07290019840244 ()
7290019840244

  • 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
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 has a treatment surface with 3 electrodes and a control button with 5 surrounding indicator lights. The device has a rechargeable battery and is for cordless use only. A wall adapter is supplied to charge the device.
SILKN BEAUTY LTD
Titan Mini
In Commercial Distribution

  • 27290019840224 ()
  • 17290019840227 ()
  • 07290019840220 ()
7290019840220

  • Radio-frequency skin surface treatment system applicator
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.
SILKN BEAUTY LTD
Motion Premium
In Commercial Distribution

  • 27290019840194 ()
  • 17290019840197 ()
  • 07290019840190 ()
7290019840190

  • 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.
SILKN BEAUTY LTD
Flash & Go Pro
In Commercial Distribution

  • 27290019840156 ()
  • 17290019840159 ()
  • 07290019840152 ()
7290019840152

  • 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.
SILKN BEAUTY LTD
BellaFlash Pro
In Commercial Distribution

  • 27290019840149 ()
  • 17290019840142 ()
  • 07290019840145 ()
7290019840145

  • Cosmetic red-light phototherapy system, home-use
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
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
An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth.
SILKN BEAUTY LTD
Infinity Fast
In Commercial Distribution

  • 27290019840026 ()
  • 17290019840029 ()
  • 07290019840022 ()
7290019840022

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

  • 17290019840005 ()
  • 07290019840008 ()
  • 27290019840033 ()
7290019840008

  • Radio-frequency skin surface treatment system applicator
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
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