# K220506: SkinPen Precision System

- Pathway: 510(k) (Special)
- Applicant: Crown Aesthetics
- Decided: Mar 7, 2022 after 13 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: 3 generations back to DEN160029 (2018). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202243: SkinPen Precision System, Crown Aesthetics (2021) Summary page 4.

## Most influential descendants
- 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
- K231073: SkinStylus SteriLock® MicroSystem, Model Number MP1209SL (2023), 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/K220506
Methodology: https://510kreport.com/methodology