XCELLARISPRO TWIST microneedling device

Primary DI
04260446131065
Brand
XCELLARISPRO TWIST microneedling device
Company
Dermaroller GmbH
Model
VK-3000.002.02
Device description
A microneedling device for aesthetic using one or more needles to mechanically puncture and injure skin tissue for aesthetic use for the treatment of facial acne scars and wrinkles. The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables.Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch.Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.
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
04260446131065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260446131065042604461310654260446131065

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needling electronic handpiece, professionalA hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.

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
04260446131072XCELLARISPRO TWIST Control unitVK-2000.010.01VK-2000.010.012025-08-26
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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04260446131072XCELLARISPRO TWIST Control unitDermaroller GmbHQAI2025-08-26
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