# ONA: Computer Assisted Hair Harvesting System

- Device class: 2; regulation: 21 CFR 882.4560; FDA's rule: 510(k) required
- FDA decisions: 4
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2011: 1
- 2013: 2
- 2018: 1

## Most-cited predicates
- K103428: The Artas System From Restoration Robotics (2011), cited by 2
- K123548: The Artas System (2013), cited by 1

Source page: https://510kreport.com/product-code/ONA
Data by year (CSV): https://510kreport.com/product-code/ONA.csv