XCELLARISPRO TWIST Handpiece VK-2000.011.01

GUDID 04260446131089

XCELLARISPRO TWIST Handpiece is a component of the XCELLARISPRO TWIST microneedling system

Dermaroller GmbH

Cosmetic micro-needling electronic handpiece, professional
Primary Device ID04260446131089
NIH Device Record Key0625824f-e7ef-4060-a10d-20ef4615b084
Commercial Distribution StatusIn Commercial Distribution
Brand NameXCELLARISPRO TWIST Handpiece
Version Model NumberVK-2000.011.01
Catalog NumberVK-2000.011.01
Company DUNS341978822
Company NameDermaroller GmbH
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260446131089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QAIPowered Microneedle Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-03
Device Publish Date2025-08-26

Devices Manufactured by Dermaroller GmbH

04260446131102 - XCELLARISPRO barrier sleeve2025-09-03 BARRIER SLEEVE for Microneedling Device The XCELLARISPRO barrier sleeve is a disposable consumable that is to be used with the X
04260446131065 - XCELLARISPRO TWIST microneedling device2025-09-03 A microneedling device for aesthetic using one or more needles to mechanically puncture and injure skin tissue for aesthetic use
04260446131072 - XCELLARISPRO TWIST Control unit2025-09-03 The control unit is one component of the XCELLARISPRO TWIS microneedling system.
04260446131089 - XCELLARISPRO TWIST Handpiece2025-09-03XCELLARISPRO TWIST Handpiece is a component of the XCELLARISPRO TWIST microneedling system
04260446131089 - XCELLARISPRO TWIST Handpiece2025-09-03 XCELLARISPRO TWIST Handpiece is a component of the XCELLARISPRO TWIST microneedling system
04260446136268 - XCELLARISPRO Needling Module2025-09-03 XCELLARISPRO Needling Modules for Microneedling Device The needling module is a consumable to be used with the XCELLARISPRO micr

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.