FDA.reportPublic FDA data

XCELLARISPRO TWIST Control unit

Primary DI
04260446131072
Brand
XCELLARISPRO TWIST Control unit
Company
Dermaroller GmbH
Model
VK-2000.010.01
Catalog number
VK-2000.010.01
Device description
The control unit is one component of the XCELLARISPRO TWIS microneedling system.
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QAIPowered Microneedle Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAIPowered Microneedle DeviceGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241790000XCELLARISPRO TWIST microneedling deviceDermaroller GmbH2025-03-06QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260446131072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260446131072042604461310724260446131072

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341978822
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260446131058XCELLARISPRO barrier sleeveVK-5700-001.01VK-5700-001.012025-08-26
04260446131102XCELLARISPRO barrier sleeveVK-5700-001.01VK-5700-001.012025-08-26
04260446131065XCELLARISPRO TWIST microneedling deviceVK-3000.002.022025-08-26
04260446131089XCELLARISPRO TWIST HandpieceVK-2000.011.01VK-2000.011.012025-08-26
04260446136268XCELLARISPRO Needling ModuleVK-5700.625.03VK-5700.625.032025-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EMTDEMNPA4906USMP06-MNP 1.5 Exceed USMT.DERM GmbHQAI2026-05-22
EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0MT.DERM GmbHQAI2026-05-22
EMTDEMNPEY06USMP06-MNP 1.5 Exceed II 3.0MT.DERM GmbHQAI2026-05-22
08800016000443E-PENBOMTECH ELECTRONICS CO., LTD.QAI2026-04-29
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00860015460608LuxPenT AESTHETICS LLCQAI2026-03-12
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080555980600681NEED ProCAMPOMATS SRLQAI2025-12-03
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080555980600821NEED Pro Cartridges CAMPOMATS SRLQAI2025-12-03
B933ELSYS02R0ellacorCytrellis Biosystems, Inc.QAI2025-10-20
04260446131058XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
04260446131102XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
04260446131065XCELLARISPRO TWIST microneedling deviceDermaroller GmbHQAI2025-08-26
04260446131089XCELLARISPRO TWIST HandpieceDermaroller GmbHQAI2025-08-26
04260446136268XCELLARISPRO Needling ModuleDermaroller GmbHQAI2025-08-26
B933EL03N029EllacorCytrellis Biosystems, Inc.QAI2025-06-12
00860012651016CytoPen NGEMAGE MEDICAL LLCQAI2025-05-22
00860012651030CytoPen S2EMAGE MEDICAL LLCQAI2025-05-22
00850061586018NanoPen Zizion Group Inc.QAI2024-12-26