# K241790: XCELLARISPRO TWIST microneedling device

- Pathway: 510(k) (Traditional)
- Applicant: Dermaroller GmbH
- Decided: Mar 6, 2025 after 258 days
- Product code: QAI (Powered Microneedle Device)
- Device class: 2
- Regulation: 21 CFR 878.4430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN160029 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182407: Exceed Microneedling device, Mt. Derm GmbH (2019) Summary page 5.
- K180778: Exceed Microneedling Device, Mt. Derm GmbH (2018) Summary page 5.
- DEN160029: SkinPen Precision System, Bellus Medical, LLC (2018) Summary page 5.

## Indications for use
The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types 1, 11, 111 and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types 1, 11 and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

Source page: https://510kreport.com/device/K241790
Methodology: https://510kreport.com/methodology