# K221011: AI.ME System

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept USA, Inc.
- Decided: Dec 20, 2022 after 259 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 4.

## Indications for use
The AI.ME system is indicated for fractional skin resurfacing.

Source page: https://510kreport.com/device/K221011
Methodology: https://510kreport.com/methodology