# K103428: The Artas System From Restoration Robotics

- Pathway: 510(k) (Traditional)
- Applicant: Restoration Robotics, Inc.
- Decided: Apr 4, 2011 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: 7 generations back to K930667 (1994). 37 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952737: Calvitron Hair Transplant System, Medicamat S.A. (1995) Summary page 1.
- K072629: Digimatch Robodoc Surgical System, Integrated Surgical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- K123548: The Artas System (2013), 1 descendant of its own
- K173358: ARTAS System (2018), 0 descendants of its own
- K123154: Artas System From Restoration Robotics (2013), 0 descendants of its own

## 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/K103428
Methodology: https://510kreport.com/methodology