XCELLARISPRO TWIST microneedling device

GUDID 04260446131065

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.

Dermaroller GmbH

Cosmetic micro-needling electronic handpiece, professional

• Primary Device ID: 04260446131065
• NIH Device Record Key: ef02576b-0d61-4158-a008-46e3e544015c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XCELLARISPRO TWIST microneedling device
• Version Model Number: VK-3000.002.02
• Company DUNS: 341978822
• Company Name: Dermaroller GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260446131065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241790

FDA Product Code

• QAI: Powered Microneedle Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

Devices Manufactured by Dermaroller GmbH

• 04260446131102 - XCELLARISPRO barrier sleeve: 2025-09-03 BARRIER SLEEVE for Microneedling Device The XCELLARISPRO barrier sleeve is a disposable consumable that is to be used with the X
• 04260446131065 - XCELLARISPRO TWIST microneedling device: 2025-09-03A 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.
• 04260446131065 - XCELLARISPRO TWIST microneedling device: 2025-09-03 A microneedling device for aesthetic using one or more needles to mechanically puncture and injure skin tissue for aesthetic use
• 04260446131072 - XCELLARISPRO TWIST Control unit: 2025-09-03 The control unit is one component of the XCELLARISPRO TWIS microneedling system.
• 04260446131089 - XCELLARISPRO TWIST Handpiece: 2025-09-03 XCELLARISPRO TWIST Handpiece is a component of the XCELLARISPRO TWIST microneedling system
• 04260446136268 - XCELLARISPRO Needling Module: 2025-09-03 XCELLARISPRO Needling Modules for Microneedling Device The needling module is a consumable to be used with the XCELLARISPRO micr