# K200044: SkinStylus SteriLock MicroSystem

- Pathway: 510(k) (Traditional)
- Applicant: Esthetic Education, LLC
- Decided: Apr 10, 2020 after 93 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.
2 later devices descend from it; 1 cites it directly.
0 of 4 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 4.

## Most influential descendants
- K241355: SER Pen Carain MicroSystem (MP1209SP) (2024), 1 descendant of its own
- K253153: SER Pen Carain MicroSystem (MP1209SP) (2025), 0 descendants of its own

## Indications for use
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

Source page: https://510kreport.com/device/K200044
Methodology: https://510kreport.com/methodology