# K233709: Exceed Unlimited

- Pathway: 510(k) (Traditional)
- Applicant: Mt. Derm GmbH
- Decided: Feb 23, 2024 after 95 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 6.

## Indications for use
The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I, II and/or Ill in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older. The Exceed Unlimited 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, Ill and IV in adults aged 22 years or older.

Source page: https://510kreport.com/device/K233709
Methodology: https://510kreport.com/methodology