Xcellarispro Twist Microneedling Device
Xcellarispro Twist is a microneedling system for improving facial acne scars and specified facial wrinkles in adults aged 22 years or older. Acne-scar treatment covers Fitzpatrick skin…
Xcellarispro Twist is a microneedling system for improving facial acne scars and specified facial wrinkles in adults aged 22 years or older. Acne-scar treatment covers Fitzpatrick skin types I to IV; wrinkle treatment covers types I to III.
A motorized handpiece drives a sterile six-needle stainless-steel module to puncture epidermal and dermal tissue. The system includes a control unit, power supply and optional foot switch, with a disposable barrier sleeve covering the handpiece.
Listed Item
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.
Depth and Frequency
Needle stroke frequency adjusts from 50 to 150 Hz. Protrusion adjusts from 0 to 2.5 mm, with a recommended maximum penetration of 1.5 mm. Wrinkle treatment areas are glabellar frown lines, periorbital lines and cheek folds; the needle module is single use.
Who Else Makes It
Concentrated in Beijing (4), Guangdong (4), Hebei (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Hebei Lufen Tech Co., Limited | Xingtai | Hebei | Contract manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
| Guangzhou Ekai Electronic Technology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Guangdong Carain Beauty Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Dermaroller GmbH, Germany |
|---|---|
| FDA product code | QAI |
| Device type | Powered Microneedle Device |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4430 |
| Establishment | Manufacturer |
| 510(k) | K241790 |
| Record published | 2025-08-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VK-3000.002.02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ellacor | Cytrellis Biosystems, Inc. | 25 |
| Collagen P.I.N. | Induction Therapies, LLC | 9 |
| Footswitch | Mt.derm GmbH | 5 |
| SkinPen Precision Elite | Bellus Medical, LLC | 4 |
| Exceed | Mt.derm GmbH | 4 |
| Safety Needle Cartridge 6-MNP 1.5 Exceed US | Mt.derm GmbH | 3 |
| SkinPen Precision Treatment Kits | Bellus Medical, LLC | 3 |
| CytoPen S2 | Emage Medical, LLC | 3 |
| Dp4 | Equipmed USA B.V. | 3 |
| PRO Pen Microneedling System | Dermalogica, LLC | 1 |
| Xcellarispro Twist Control unit | Dermaroller GmbH | 1 |
| Eclipse EVO Microneedling Cartridge | Eclipse, Inc. | 1 |
Showing 12 of 43. All products under Powered Microneedle Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241790 | 2025-03-06 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.