# K123154: Artas System From Restoration Robotics

- Pathway: 510(k) (Traditional)
- Applicant: Restoration Robotics, Inc.
- Decided: Feb 19, 2013 after 133 days
- Product code: ONA (Computer Assisted Hair Harvesting System)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930667 (1994). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103428: The Artas System From Restoration Robotics, Restoration Robotics, Inc. (2011) Summary page 2.

## Indications for use
The ARTAS System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.

Source page: https://510kreport.com/device/K123154
Methodology: https://510kreport.com/methodology