# K253153: SER Pen Carain MicroSystem (MP1209SP)

- Pathway: 510(k) (Special)
- Applicant: Su-Ko Technologies, LLC
- Decided: Oct 29, 2025 after 33 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: 6 generations back to DEN160029 (2018). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241355: SER Pen Carain MicroSystem (MP1209SP), Su-Ko Technologies, LLC (2024) Summary page 5.

## Indications for use
The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and 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/K253153
Methodology: https://510kreport.com/methodology