# K252752: ellacor System with Micro-Coring Technology

- Pathway: 510(k) (Traditional)
- Applicant: Cytrellis Biosystems, Inc.
- Decided: Oct 30, 2025 after 62 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)
- K202517: Cytrellis Dermal Micro-Coring System, Cytrellis Biosystems, Inc. (2021) Summary page 5.

## Indications for use
The ellacor System with Micro-Coring Technology is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. It is further indicated for Fractional Skin Resurfacing.

Source page: https://510kreport.com/device/K252752
Methodology: https://510kreport.com/methodology