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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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Sculpt I.Q. - D74666614201

Upgrade Package, 660nm wavelength
DENTSPLY SIRONA ORTHODONTICS INC.
6661420
Not in Commercial Distribution

  • D74666614201 ()
6661420

  • Dental diode laser system

Sculpt I.Q. - D74666595561

Wireless Foot Control
DENTSPLY SIRONA ORTHODONTICS INC.
6659556
Not in Commercial Distribution

  • D74666595561 ()
6659556

  • Dental diode laser system

Sculpt I.Q. - D74666593091

MultiTip 8mm, therapy light guide
DENTSPLY SIRONA ORTHODONTICS INC.
6659309
Not in Commercial Distribution

  • D74666593091 ()
6659309

  • Dental diode laser system

Sculpt I.Q. - D74666592911

EasyTip Endo Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659291
Not in Commercial Distribution

  • D74666592911 ()
  • D74666592910 ()
6659291

  • Dental diode laser system

Sculpt I.Q. - D74666592831

EasyTip 320 Pack 25
DENTSPLY SIRONA ORTHODONTICS INC.
6659283
Not in Commercial Distribution

  • D74666592831 ()
  • D74666592830 ()
6659283

  • Dental diode laser system

Sculpt I.Q. - D74666592421

Laser protective goggle for patient
DENTSPLY SIRONA ORTHODONTICS INC.
6659242
Not in Commercial Distribution

  • D74666592421 ()
6659242

  • Dental diode laser system

Sculpt I.Q. - D74666592341

Laser protective goggles for spectacle wearers
DENTSPLY SIRONA ORTHODONTICS INC.
6659234
Not in Commercial Distribution

  • D74666592341 ()
6659234

  • Dental diode laser system

Sculpt I.Q. - D74666592261

Laser protective goggles
DENTSPLY SIRONA ORTHODONTICS INC.
6659226
Not in Commercial Distribution

  • D74666592261 ()
6659226

  • Dental diode laser system

Sculpt I.Q. - D74666592181

Fibercutter
DENTSPLY SIRONA ORTHODONTICS INC.
6659218
Not in Commercial Distribution

  • D74666592181 ()
6659218

  • Dental diode laser system

Sculpt I.Q. - D74666592001

EasyBend - Bending tool
DENTSPLY SIRONA ORTHODONTICS INC.
6659200
Not in Commercial Distribution

  • D74666592001 ()
6659200

  • Dental diode laser system

Sculpt I.Q. - D74666591921

Optic protection cap for handpiece (5 pieces)
DENTSPLY SIRONA ORTHODONTICS INC.
6659192
Not in Commercial Distribution

  • D74666591921 ()
  • D74666591920 ()
6659192

  • Dental diode laser system

Sculpt I.Q. - D74666591841

Handpiece sleeve with keypad
DENTSPLY SIRONA ORTHODONTICS INC.
6659184
Not in Commercial Distribution

  • D74666591841 ()
6659184

  • Dental diode laser system

Sculpt I.Q. - D74666591011

Sculpt I.Q. Laser, USA
DENTSPLY SIRONA ORTHODONTICS INC.
6659101
Not in Commercial Distribution

  • D74666591011 ()
6659101

  • Dental diode laser system

Diode 755nm Alex Applicator for Soprano Titanium (Black) - 17290110123526

Diode 755nm Alex Applicator for Soprano Titanium (Black)
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110123526 ()
AASP28012401

  • Dermatological diode laser system

Soprano Titanium System 230V - 17290110121829

The Alma Lasers Soprano Titanium Laser System consists of: •System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts) •Operator control panel with touch-screen technology (GUI) •Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously Premarket Notification Traditional 510(k) Section 8: Page 2 of 4 Alma Lasers Soprano Titanium • 810 nm applicator • 755 nm applicator • Small NIR applicator • Footswitch and other laser safety accessories
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121829 ()
AASP05091845BSR0001

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system

Diode 3D Trio 4cm HP for Soprano Titanium - 17290110121812

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121812 ()
AASP30111208

  • Dermatological diode laser system
  • Intense pulsed light skin surface treatment system

NIR Module - 17290110121676

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121676 ()
AAIR02031605

  • Multi-modality skin surface treatment system

NIR Module - 17290110121669

Nir Face (6) HP for Soprano Ice Platinum Edition\Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121669 ()
AAIR02031604

  • Multi-modality skin surface treatment system

Diode 810nm2 cm2 HP - 17290110121652

Diode 810nm Speed 2cm HP for Soprano Ice Platinum Edition / Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121652 ()
AASP30111205

  • Dermatological diode laser system

Diode Alex 755nm - 17290110121645

Diode 755nm Alex 1.5cm HP for Soprano Ice Platinum Edition/Titanium
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121645 ()
AASP02031603

  • Dermatological diode laser system

Diode 810nm 1.2 cm2 HP - 17290110121638

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121638 ()
AASP02031602

  • Dermatological diode laser system

Trio Diode Laser Module - 17290110121621

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121621 ()
AASP02031601

  • Dermatological diode laser system

Unipolar HP - 17290110121614

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121614 ()
AASR11021407

  • Radio-frequency skin/body contouring system

Diode 810nm Compact For Soprano Ice - 17290110121591

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121591 ()
AASP13091303

  • Multi-modality skin surface treatment system

Soprano Ice Platinum Edition System 110-120V (Black/Gold) - 17290110121416

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121416 ()
AASP14021601BGA0001

  • Multi-modality skin surface treatment system

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 - 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

Icoone Laser Body - 18057592610369

Icoone Laser Body (also referred to as Icoone body laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 611BC14) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
Icoone laser body (also referred to as Icoone body laser)
In Commercial Distribution

  • 18057592610369 ()

  • Pressure: 20 KiloPascal
611BC14

  • Freestanding electric massager

Icoone Laser - 18057592610307

Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 610BEC04) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
Icoone Laser (also referred to as Icoone beauty laser)
In Commercial Distribution

  • 18057592610307 ()

  • Pressure: 20 KiloPascal
610BC04

  • Freestanding electric massager

Icoone Laser Med - 18057592610277

Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) Through the display, the light sources can be fully deactivated, or both activated, or only LED activated. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
ICOONE Laser Med (also called ICOONE MEDICAL LASER)
In Commercial Distribution

  • 18057592610277 ()

  • Pressure: 20 KiloPascal
650EC24

  • Freestanding electric massager

icoone Laser Healthcare - 18057592610246

Icoone h (also referred to as Icoone LASER and icoone-h LASER) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone h (also referred to as Icoone LASER and icoone-h LASER) model ref 601EC14 is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
In Commercial Distribution

  • 18057592610246 ()

  • Pressure: 20 KiloPascal
601EC14

  • Freestanding electric massager

Bipolar HP - 17290110121607

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121607 ()
AASR11021401

  • Radio-frequency skin/body contouring system

Soprano Pontiac White / Black System 220V - 17290110121492

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121492 ()
AASP18021504WR0001

  • Multi-modality skin surface treatment system

Diode 1064nm Compact For Soprano - 17290110121409

No Description
ALMA LASERS LTD.
1
In Commercial Distribution

  • 17290110121409 ()
AASP10121401

  • Multi-modality skin surface treatment system

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

Flexicare - 05055931131861

Adult Smoothbore BiPAP Breathing System 1.8m
FLEXICARE MEDICAL LIMITED
038-35-300/2U
In Commercial Distribution

  • 05055931131861 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119692

1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 1
FLEXICARE MEDICAL LIMITED
NF-158-1U
In Commercial Distribution

  • 05055931119692 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119685

1.8m (70") Oxygen Line 2.1m (82") and Round Masks Size 0
FLEXICARE MEDICAL LIMITED
NF-158-0U
In Commercial Distribution

  • 05055931119685 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119678

1.8m (70") with Anatomical Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-157U
In Commercial Distribution

  • 05055931119678 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit T-Piece Circuit - 05055931119661

1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 1
FLEXICARE MEDICAL LIMITED
NF-157-1U
In Commercial Distribution

  • 05055931119661 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119654

1.8m (70") Oxygen Line 2.1m (82") Anatomical Mask Size 0
FLEXICARE MEDICAL LIMITED
NF-157-0U
In Commercial Distribution

  • 05055931119654 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119647

No Description
FLEXICARE MEDICAL LIMITED
NF-156U
In Commercial Distribution

  • 05055931119647 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119630

1.8m (70") with Anatomical Masks Sizes 0 + 1
FLEXICARE MEDICAL LIMITED
NF-156-NTU
In Commercial Distribution

  • 05055931119630 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119623

1.8m (70") Oxygen Line 2.1m (82") Round Masks Sizes 0 + 1
FLEXICARE MEDICAL LIMITED
NF-155U
In Commercial Distribution

  • 05055931119623 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119616

1.8m (70") with Round Masks Sizes 0 + 1
FLEXICARE MEDICAL LIMITED
NF-155-NTU
In Commercial Distribution

  • 05055931119616 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitator T-Piece Circuit with Adjustable PEEP - 05055931119609

No Description
FLEXICARE MEDICAL LIMITED
NF-150U
In Commercial Distribution

  • 05055931119609 ()


  • Ventilator breathing circuit, single-use

Infant Resuscitation Kit. T-Piece Circuit - 05055931119579

1.8m (70") Oxygen Line 2.1m (82") Catheter Access Adapter
FLEXICARE MEDICAL LIMITED
NF-056U
In Commercial Distribution

  • 05055931119579 ()


  • Ventilator breathing circuit, single-use

Neoforce - 05055931117636

Infant Resuscitator T-Piece Circuit 1.9m (75") with Tethered Cap and Adjustable PEEP
FLEXICARE MEDICAL LIMITED
NF-151U
In Commercial Distribution

  • 05055931117636 ()


  • Ventilator breathing circuit, single-use

FL9000 - 05055931112983

Respiratory Humidifier Single Use Temperature Probe (Sterile)
FLEXICARE MEDICAL LIMITED
FL9000-04STRU
In Commercial Distribution

  • 05055931112983 ()


  • Heated respiratory humidifier

FL9000 - 05055931111009

Respiratory Humidifier Single Use Temperature Probe
FLEXICARE MEDICAL LIMITED
FL9000-04U
In Commercial Distribution

  • 05055931111009 ()


  • Heated respiratory humidifier
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