# K182407: Exceed Microneedling device

- Pathway: 510(k) (Traditional)
- Applicant: Mt. Derm GmbH
- Decided: Jul 19, 2019 after 318 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: 1 generation back to DEN160029 (2018). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160029: SkinPen Precision System, Bellus Medical, LLC (2018) Summary page 5.

## Most influential descendants
- K241790: XCELLARISPRO TWIST microneedling device (2025), 0 descendants of its own
- K233709: Exceed Unlimited (2024), 0 descendants of its own

## Indications for use
The Exceed is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.

Source page: https://510kreport.com/device/K182407
Methodology: https://510kreport.com/methodology