Identity
- Trade Name
- XCELLARISPRO Needling Module FDA UDI
- Generic Name
- Cosmetic micro-needling electronic handpiece cartridge, professional FDA UDI
- Device Name
- XCELLARISPRO Needling Modules for Microneedling Device The needling module is a consumable to be used with the XCELLARISPRO microneedling system. It contains a needle cushion containing 6 stainless steel microneedles in squared arrangement, each 2.5 mm in length, and it is the patient-touching component. The needling module is mounted into the handpiece and safely secured by a metal flap with magnets.It is provided sterile and for single use only. FDA UDI
- Model / Reference
- VK-5700.625.03 FDA UDI
- Description
- XCELLARISPRO Needling Modules for Microneedling Device The needling module is a consumable to be used with the XCELLARISPRO microneedling system. It contains a needle cushion containing 6 stainless steel microneedles in squared arrangement, each 2.5 mm in length, and it is the patient-touching component. The needling module is mounted into the handpiece and safely secured by a metal flap with magnets.It is provided sterile and for single use only. FDA UDI
Identifiers
- Catalog Number
- VK-5700.625.03 FDA UDI
- Primary DI / UDI-DI
- 04260446136268 FDA UDI
- 510(k) Number
- K241790 FDA UDI
- FDA Product Code
- QAI FDA UDI
- GMDN Term
- Cosmetic micro-needling electronic handpiece cartridge, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4430 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cosmetic micro-needling electronic handpiece cartridge, professional
XCELLARISPRO Needling Module by Dermaroller GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cosmetic micro-needling electronic handpiece cartridge, professional.
- Dp4 — Equipmed USA B.V. · Class II
- Eclipse MicroPen Elite — Eclipse, Inc.
- Collagen P.I.N. — INDUCTION THERAPIES, LLC · Class II
- Eclipse EVO Microneedling Cartridge — Eclipse, Inc. · Class II
- EndyMed Intensif 10 pack tips package — ENDYMED MEDICAL LTD · Class II
- Collagen P.I.N. — INDUCTION THERAPIES, LLC · Class II
- SkinPen Precision Treatment Kit — BELLUS MEDICAL, LLC · Class II
- Ellacor — CYTRELLIS BIOSYSTEMS, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dermaroller GmbH
Sources (1)
- FDA UDI b482a72f-1b69-4a27-9fb1-9965fdf80c01 35 fields · synced May 31, 2026