# K180778: Exceed Microneedling Device

- Pathway: 510(k) (Traditional)
- Applicant: Mt. Derm GmbH
- Decided: Sep 7, 2018 after 165 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.
13 later devices descend from it; 4 cite it directly.
0 of 15 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
- K202243: SkinPen Precision System (2021), 7 descendants of its own
- K220506: SkinPen Precision System (2022), 5 descendants of its own
- K222199: Collagen P.I.N. (Percutaneous Induction Needling) (2022), 3 descendants of its own
- K202517: Cytrellis Dermal Micro-Coring System (2021), 2 descendants of its own
- K241355: SER Pen Carain MicroSystem (MP1209SP) (2024), 1 descendant of its own

## Indications for use
The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II 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/K180778
Methodology: https://510kreport.com/methodology