# DEN160029: SkinPen Precision System

- Pathway: De Novo (Direct)
- Applicant: Bellus Medical, LLC
- Decided: Mar 1, 2018 after 604 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
No predicates in its family tree.
25 later devices descend from it; 9 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K180778: Exceed Microneedling Device (2018), 13 descendants of its own
- K202243: SkinPen Precision System (2021), 7 descendants of its own
- K220506: SkinPen Precision System (2022), 5 descendants of its own
- K230420: Dr. pen Microneedling System (2023), 3 descendants of its own
- K222199: Collagen P.I.N. (Percutaneous Induction Needling) (2022), 3 descendants of its own

## Indications for use
SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.

Source page: https://510kreport.com/device/DEN160029
Methodology: https://510kreport.com/methodology