XCELLARISPRO TWIST microneedling device
Dermaroller GmbH
Dermaroller GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007361698 | 3007361698 | Dermaroller GmbH | 1 | N | 2026-01-01 | Wilhelm-Mast-Str. 8 Wolfenbuettel Lower Saxony DE 38304 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 129836 | 1607535734 | K241790 | XCELLARISPRO TWIST microneedling device | QAI | 2025-03-06 |
| 129836 | 1122405251 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QAI | 1 | 2025-03-06 |
PMN#
GUDID#
XCELLARISPRO barrier sleeve - 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.
2025-08-26
XCELLARISPRO barrier sleeve - BARRIER SLEEVE for Microneedling Device The 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.
2025-08-26
XCELLARISPRO TWIST microneedling device - 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.
2025-08-26
XCELLARISPRO TWIST Control unit - The control unit is one component of the XCELLARISPRO TWIS microneedling system.
2025-08-26
XCELLARISPRO TWIST Handpiece - XCELLARISPRO TWIST Handpiece is a component of the XCELLARISPRO TWIST microneedling system
2025-08-26
XCELLARISPRO Needling Module - XCELLARISPRO Needling Modules for Microneedling DeviceThe 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.
2025-08-26