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. Cvr. (1Hr) 10-Pk, VelaShape II
SYNERON MEDICAL LTD
KT71751
Not in Commercial Distribution

  • 37290109950359 ()
KT71751

  • Multi-modality skin contouring system
STOP X MODEL STOP U PACKED GRADIENT RED USA
POLLOGEN LTD
STOP U
In Commercial Distribution

  • 07290018007686 ()
34300010GR-US

  • Multi-modality skin contouring system
The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures.
ENDYMED MEDICAL LTD
PURE DentA 110V
In Commercial Distribution

  • 07290016814668 ()
ND_PRD00480-00

  • Multi-modality skin contouring system
The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite.
ENDYMED MEDICAL LTD
Contour MAX Handpiece
Not in Commercial Distribution

  • 07290016814477 ()
ND_PRD00467-00

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Mini Shaper MAX Handpiece
Not in Commercial Distribution

  • 07290016814460 ()
ND_PRD00468-00

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System Body 2200V
Not in Commercial Distribution

  • 07290016814194 ()
ND_PRD00009_F_B

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System 220V
Not in Commercial Distribution

  • 07290016814187 ()
ND_PRD00009_F

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System Face 110V
In Commercial Distribution

  • 07290016814170 ()
ND_PRD00006_F_F

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System Body 110V
In Commercial Distribution

  • 07290016814163 ()
ND_PRD00006_F_B

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System 110V
In Commercial Distribution

  • 07290016814156 ()
ND_PRD00006_F

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Pro Shaper Handpiece
In Commercial Distribution

  • 07290016814149 ()
ND_PRD00093

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Pro iFine Handpiece
In Commercial Distribution

  • 07290016814132 ()
ND_PRD00036

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Pro Small Handpiece
In Commercial Distribution

  • 07290016814101 ()
ND_PRD00005

  • Multi-modality skin contouring system
The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite.
ENDYMED MEDICAL LTD
Countour Handpiece
In Commercial Distribution

  • 07290016814088 ()
ND_PRD00180

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
mini-shaper Handpiece
In Commercial Distribution

  • 07290016814071 ()
ND_PRD00179

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
mini-shaper Handpiece
In Commercial Distribution

  • 07290016814057 ()
ND_PRD00178

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Shaper Handpiece
In Commercial Distribution

  • 07290016814040 ()
ND_PRD00097

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
iFine Handpiece
In Commercial Distribution

  • 07290016814033 ()
ND_PRD00075

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pure system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Small Handpiece
In Commercial Distribution

  • 07290016814019 ()
ND_PRD00074

  • Multi-modality skin contouring system
RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA Configuration (also abbreviated 'U').
POLLOGEN LTD
RF PRO handpiece kit for GENEO X system (USA Configuration)
Not in Commercial Distribution

  • 07290016586671 ()
25000510E

  • Multi-modality skin contouring system
No Description
POLLOGEN LTD
STOP VX2 MODEL U
In Commercial Distribution

  • 07290016586626 ()
34690000BK-US

  • Multi-modality skin contouring system
No Description
POLLOGEN LTD
STOP U MODEL UXV
In Commercial Distribution

  • 07290016586466 ()
34650000GL-US

  • Multi-modality skin contouring system
TRIPOLLAR DESIRE PACKED ROSE GOLD USA
POLLOGEN LTD
Desire model U
Not in Commercial Distribution

  • 07290016586459 ()
34670000RG-US

  • Multi-modality skin contouring system
No Description
POLLOGEN LTD
STOP U MODEL UXV
In Commercial Distribution

  • 07290016586442 ()
34650000BP-US

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
Shaper MAX Handpiece
Not in Commercial Distribution

  • 07290016814453 ()
ND_PRD00466-00

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
iFine MAX Handpiece
Not in Commercial Distribution

  • 07290016814446 ()
ND_PRD00469-00

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.
ENDYMED MEDICAL LTD
FSR MAX Handpiece
Not in Commercial Distribution

  • 07290016814439 ()
ND_PRD00471-00

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed Pro MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Small MAX Handpiece
Not in Commercial Distribution

  • 07290016814422 ()
ND_PRD00470-00

  • Multi-modality skin contouring system
Tips that are used with the FSR handpiece
ENDYMED MEDICAL LTD
FSR 10 Tips Package - sterile
In Commercial Distribution

  • 07290016814347 ()
ND_PRD00435

  • Multi-modality skin contouring system
The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.
ENDYMED MEDICAL LTD
Pure 85W system 220V
Not in Commercial Distribution

  • 07290016814293 ()
ND_PRD00088-01

  • Multi-modality skin contouring system
The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.
ENDYMED MEDICAL LTD
Pure system 220V
Not in Commercial Distribution

  • 07290016814286 ()
ND_PRD00077

  • Multi-modality skin contouring system
The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.
ENDYMED MEDICAL LTD
Pure 2.0 system 110V PURE logo
In Commercial Distribution

  • 07290016814279 ()
ND_PRD00413-00

  • Multi-modality skin contouring system
The EndyMed Pure System is a noninvasive device intended for use in Dermatologic and General Surgical procedure.
ENDYMED MEDICAL LTD
Pure 2.0 system 220V PURE logo
Not in Commercial Distribution

  • 07290016814231 ()
ND_PRD00208

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System Face 220V
Not in Commercial Distribution

  • 07290016814224 ()
ND_PRD00009_F_F

  • Multi-modality skin contouring system
Reaction™
VIORA LTD
VRE0110
In Commercial Distribution

  • 07290016746303 ()
VRE0110

  • Multi-modality skin contouring system
V-FORM
VIORA LTD
VTL45900
In Commercial Distribution

  • 07290016746259 ()
VTL45900

  • Multi-modality skin contouring system
LA Replaceable Cover (4 Hr) 5-Pk, Velashape III
SYNERON MEDICAL LTD
KT75102
Not in Commercial Distribution

  • 17290109952212 ()
KT75102

  • Multi-modality skin contouring system
LA Repl. Stacking Covers 8 Hr 5-Pk, VelaShape II
SYNERON MEDICAL LTD
KT74831
Not in Commercial Distribution

  • 17290109952151 ()
KT74831

  • Multi-modality skin contouring system
SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape III
SYNERON MEDICAL LTD
KT75071
Not in Commercial Distribution

  • 17290109950430 ()
KT75071

  • Multi-modality skin contouring system
SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III
SYNERON MEDICAL LTD
KT75671
Not in Commercial Distribution

  • 17290109950423 ()
KT75671

  • Multi-modality skin contouring system
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