# K202243: SkinPen Precision System

- Pathway: 510(k) (Traditional)
- Applicant: Crown Aesthetics
- Decided: Apr 2, 2021 after 235 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.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180778: Exceed Microneedling Device, Mt. Derm GmbH (2018) Summary page 4.

## Most influential descendants
- K220506: SkinPen Precision System (2022), 5 descendants of its own
- K222199: Collagen P.I.N. (Percutaneous Induction Needling) (2022), 3 descendants of its own
- K241355: SER Pen Carain MicroSystem (MP1209SP) (2024), 1 descendant of its own
- K253153: SER Pen Carain MicroSystem (MP1209SP) (2025), 0 descendants of its own
- K241400: SkinPen Precision Elite System (2024), 0 descendants of its own

## Indications for use
The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

Source page: https://510kreport.com/device/K202243
Methodology: https://510kreport.com/methodology