# K202517: Cytrellis Dermal Micro-Coring System

- Pathway: 510(k) (Traditional)
- Applicant: Cytrellis Biosystems, Inc.
- Decided: Jul 9, 2021 after 311 days
- Product code: QAI (Powered Microneedle Device)
- Device class: 2
- Regulation: 21 CFR 878.4430
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN160029 (2018). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180778: Exceed Microneedling Device, Mt. Derm GmbH (2018) Summary page 5.

## Most influential descendants
- K252752: ellacor System with Micro-Coring Technology (2025), 0 descendants of its own
- K221011: AI.ME System (2022), 0 descendants of its own

## Recalls of this device
- Jun 23, 2023 · Class II · Z-2393-2023: Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potent
- Apr 7, 2023 · Class II · Z-1648-2023: Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring.

## Indications for use
The Cytrellis Dermal Micro-Coring System 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.

Source page: https://510kreport.com/device/K202517
Methodology: https://510kreport.com/methodology