# K212558: MicroPen EVO

- Pathway: 510(k) (Traditional)
- Applicant: Eclipse Medcorp, LLC
- Decided: Nov 24, 2021 after 103 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.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Eclipse MicroPen® EVO 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 Il - 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/K212558
Methodology: https://510kreport.com/methodology