STOP VX MODEL U 34650000BP-US

GUDID 07290016586442

POLLOGEN LTD

Multi-modality skin contouring system
Primary Device ID07290016586442
NIH Device Record Key8ac28c19-87bc-4b7c-98f3-c41d790afbc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTOP VX MODEL U
Version Model NumberSTOP U MODEL UXV
Catalog Number34650000BP-US
Company DUNS514905681
Company NamePOLLOGEN LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016586442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-08
Device Publish Date2021-06-30

Devices Manufactured by POLLOGEN LTD

07290016586459 - Desire model U2023-12-25 TRIPOLLAR DESIRE PACKED ROSE GOLD USA
07290016586626 - STOP VX2 MODEL U 2023-12-22
17290016586487 - triFX2022-06-07 H7X7 DISPOSABLE TIP ASSY 5 PACKED BK
07290016586497 - triFX2022-06-07 GEN100 DISPOSABLE TIP ASSY 5 PACKED BK
07290016586503 - triFX2022-06-07 GEN 36L DISPOSABLE TIP ASSY 5 PACKED BK
07290016586510 - triFX2022-06-07 GEN 36 DISPOSABLE TIP ASSY 5 PACKED BK
07290016586527 - triFX2022-06-07 GEN 12 DISPOSABLE TIP ASSY 5 PACKED BK
07290016586534 - TriLift2022-02-21

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