FDA.reportPublic FDA data

XCELLARISPRO barrier sleeve

Primary DI
04260446131058
Brand
XCELLARISPRO barrier sleeve
Company
Dermaroller GmbH
Model
VK-5700-001.01
Catalog number
VK-5700-001.01
Device description
BARRIER SLEEVE for Microneedling DeviceThe XCELLARISPRO barrier sleeve is a disposable consumable that is to be used with the XCELLARISPRO microneedling system.It covers the handpiece during each patient use to minimize the risk of cross-contamination.It is a single-use, non-sterile device.
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
04260446131058PrimaryGS10
04260446131102Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260446131058042604461310584260446131058
04260446131102042604461311024260446131102

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
341978822
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260446131102XCELLARISPRO barrier sleeveVK-5700-001.01VK-5700-001.012025-08-26
04260446131065XCELLARISPRO TWIST microneedling deviceVK-3000.002.022025-08-26
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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Primary DI, Brand, Company table
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B933ELSYS02R0ellacorCytrellis Biosystems, Inc.QAI2025-10-20
04260446131102XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
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