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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SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III
Candela Corporation
KT75672
In Commercial Distribution

  • 00817495024578 ()
KT75672

  • Multi-modality skin contouring system
SA Repl. Med. Cvr. 25x30mm (4 Hr), Velashape III
Candela Corporation
KT75072
In Commercial Distribution

  • 00817495024561 ()
  • 10817495024568 ()
KT75072

  • Multi-modality skin contouring system
SA Small Repl. Cover 10x13mm, 4Hr, Velashape III
Candela Corporation
AS83322
In Commercial Distribution

AS83322

  • Multi-modality skin contouring system
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
Candela Corporation
AS83333
In Commercial Distribution

  • 00817495024462 ()


  • Multi-modality skin contouring system
SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
Candela Corporation
AS87512
In Commercial Distribution

AS87512

  • Multi-modality skin contouring system
Replaceable Cover, Vsmooth 4Hr, Velashape III
Candela Corporation
AS85993
In Commercial Distribution

AS85993

  • Multi-modality skin contouring system
LA Replaceable Cover (4 Hr) 5-Pk, Velashape III
Candela Corporation
KT75102
In Commercial Distribution

KT75102

  • Multi-modality skin contouring system
SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape III
Candela Corporation
KT75061
In Commercial Distribution

KT75061

  • Multi-modality skin contouring system
Vsmooth Applicator, VelaShape III
Candela Corporation
FG71171
In Commercial Distribution

FG71171

  • Multi-modality skin contouring system
Vcontour Applicator, Velashape III
Candela Corporation
FG71012
In Commercial Distribution

FG71012

  • Multi-modality skin contouring system
The Thermaeye Plus is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
EL.EN. SPA
M081AN1
In Commercial Distribution

  • 08057017760443 ()
M081AN1

  • Multi-modality skin contouring system
The Minisilk-FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200nm. Emission activation is by footswitch. Overall weight of the system is 16kg, and the size is 22x37x45cm (HxWxD). Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
EL.EN. SPA
M081R1
In Commercial Distribution

  • 08057017760337 ()
M081R1

  • Multi-modality skin contouring system
FAQā„¢ 101 device is an over-the-counter home use devices intended for non-invasive treatments of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.
Foreo AB
Amethyst
In Commercial Distribution

  • 07640260120037 ()


  • Multi-modality skin contouring system
SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS87512
Not in Commercial Distribution

  • 07290109952703 ()
  • 17290109952700 ()
AS87512

  • Multi-modality skin contouring system
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS83333
Not in Commercial Distribution

  • 17290109952694 ()
  • 07290109952697 ()
AS83333

  • Multi-modality skin contouring system
VelaShape III System 120V, Packaged
SYNERON MEDICAL LTD
FG71201R
Not in Commercial Distribution

  • 07290109952437 ()
FG71201R

  • Multi-modality skin contouring system
Replaceable Cover, Vsmooth 4Hr, Velashape III
SYNERON MEDICAL LTD
AS85993
Not in Commercial Distribution

  • 07290109952215 ()
AS85993

  • Multi-modality skin contouring system
Repl. Cover,(White) LA-8Hr, Stacking, Vela Shape II
SYNERON MEDICAL LTD
AS85352
Not in Commercial Distribution

  • 07290109952154 ()
AS85352

  • Multi-modality skin contouring system
VelaShape III System 120V, Packaged
SYNERON MEDICAL LTD
FG71201
Not in Commercial Distribution

  • 07290109952031 ()
FG71201

  • Multi-modality skin contouring system
VelaShape III System 100V, Packaged
SYNERON MEDICAL LTD
FG71211
Not in Commercial Distribution

  • 07290109952024 ()
FG71211

  • Multi-modality skin contouring system
Vsmooth Applicator, VelaShape III
SYNERON MEDICAL LTD
FG71171R
Not in Commercial Distribution

  • 07290109951867 ()
FG71171R

  • Multi-modality skin contouring system
Vcontour Applicator, Velashape III
SYNERON MEDICAL LTD
FG71012R
Not in Commercial Distribution

  • 07290109951751 ()
FG71012R

  • Multi-modality skin contouring system
Vcontour Applicator (SA), VelaShape II
SYNERON MEDICAL LTD
FG70351R
Not in Commercial Distribution

  • 07290109951560 ()
FG70351R

  • Multi-modality skin contouring system
Vsmooth Applicator (LA), VelaShape II
SYNERON MEDICAL LTD
FG70341R
Not in Commercial Distribution

  • 07290109951553 ()
FG70341R

  • Multi-modality skin contouring system
Vela Shape II System 100V, Packaged
SYNERON MEDICAL LTD
FG70331R
Not in Commercial Distribution

  • 07290109951546 ()
FG70331R

  • Multi-modality skin contouring system
Vela Shape II System 115V, Packaged
SYNERON MEDICAL LTD
FG70321R
Not in Commercial Distribution

  • 07290109951539 ()
FG70321R

  • Multi-modality skin contouring system
VelasmoothPro System 100V, Packaged
SYNERON MEDICAL LTD
FG70271R
Not in Commercial Distribution

  • 07290109951508 ()
FG70271R

  • Multi-modality skin contouring system
VelasmoothPro System 115V, Packaged
SYNERON MEDICAL LTD
FG70261R
Not in Commercial Distribution

  • 07290109951492 ()
FG70261R

  • Multi-modality skin contouring system
Large Applicator, VelasmoothPro
SYNERON MEDICAL LTD
FG70241R
Not in Commercial Distribution

  • 07290109951478 ()
FG70241R

  • Multi-modality skin contouring system
Small Applicator, VelasmoothPro
SYNERON MEDICAL LTD
FG70231R
Not in Commercial Distribution

  • 07290109951461 ()
FG70231R

  • Multi-modality skin contouring system
VelaShape System 100V, Packaged
SYNERON MEDICAL LTD
FG00131R
Not in Commercial Distribution

  • 07290109951447 ()
FG00131R

  • Multi-modality skin contouring system
Vcontour Applicator (SA) ,Packaged
SYNERON MEDICAL LTD
FG00111R
Not in Commercial Distribution

  • 07290109951430 ()
FG00111R

  • Multi-modality skin contouring system
Vsmooth Applicator (LA), Packaged
SYNERON MEDICAL LTD
FG00101R
Not in Commercial Distribution

  • 07290109951423 ()
FG00101R

  • Multi-modality skin contouring system
Vela SA Appl.Pack.+ Disp.Parts for Appl.
SYNERON MEDICAL LTD
AS38211R
Not in Commercial Distribution

  • 07290109951348 ()
AS38211R

  • Multi-modality skin contouring system
Refurbished ,Vela- Pack.100Vac Assy
SYNERON MEDICAL LTD
AS24021R
Not in Commercial Distribution

  • 07290109951317 ()
AS24021R

  • Multi-modality skin contouring system
VelaSmooth Large Applicator Packaged
SYNERON MEDICAL LTD
AS20356R
Not in Commercial Distribution

  • 07290109951300 ()
AS20356R

  • Multi-modality skin contouring system
Refurbished ,Vela- Pack. 115Vac Assy
SYNERON MEDICAL LTD
AS20341R
Not in Commercial Distribution

  • 07290109951294 ()
AS20341R

  • Multi-modality skin contouring system
Repl. Cover (Dark Gray), SA-12Hr, VelaSmooth Pro
SYNERON MEDICAL LTD
AS80251
Not in Commercial Distribution

  • 07290109950600 ()
  • 17290109950607 ()
AS80251

  • Multi-modality skin contouring system
Repl. Cover, SA-4Hr, VelasmoothPro
SYNERON MEDICAL LTD
AS75402
Not in Commercial Distribution

  • 07290109950587 ()
  • 17290109950584 ()
AS75402

  • Multi-modality skin contouring system
Small Applicator, VelasmoothPro
SYNERON MEDICAL LTD
FG70231
Not in Commercial Distribution

  • 07290109950563 ()
FG70231

  • Multi-modality skin contouring system
VelasmoothPro System 100V, Packaged
SYNERON MEDICAL LTD
FG70271
Not in Commercial Distribution

  • 07290109950532 ()
FG70271

  • Multi-modality skin contouring system
Vela- Pack. 115Vac Assy
SYNERON MEDICAL LTD
AS20341
Not in Commercial Distribution

  • 07290109950471 ()
AS20341

  • Multi-modality skin contouring system
Repl. Cover (cream), SA-4Hr, VelaShape II
SYNERON MEDICAL LTD
AS77813
Not in Commercial Distribution

  • 07290109950440 ()
  • 37290109950441 ()
  • 17290109950447 ()
AS77813

  • Multi-modality skin contouring system
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS83332
Not in Commercial Distribution

  • 07290109950433 ()
AS83332

  • Multi-modality skin contouring system
SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS87511
Not in Commercial Distribution

  • 07290109950426 ()
AS87511

  • Multi-modality skin contouring system
SA Small Repl. Cover 10x13mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS83322
Not in Commercial Distribution

  • 07290109950419 ()
AS83322

  • Multi-modality skin contouring system
Vsmooth Applicator, VelaShape III
SYNERON MEDICAL LTD
FG71171
Not in Commercial Distribution

  • 07290109950402 ()
FG71171

  • Multi-modality skin contouring system
Vcontour Applicator, Velashape III
SYNERON MEDICAL LTD
FG71012
Not in Commercial Distribution

  • 07290109950396 ()
FG71012

  • Multi-modality skin contouring system
Repl. Cover (Grey), SA-1Hr, VelaShape II
SYNERON MEDICAL LTD
AS74672
Not in Commercial Distribution

  • 07290109950358 ()
AS74672

  • Multi-modality skin contouring system
Repl. Cover (Grey), LA-1Hr, VelaShape II
SYNERON MEDICAL LTD
AS74686
Not in Commercial Distribution

  • 07290109950341 ()
AS74686

  • Multi-modality skin contouring system
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