# K123548: The Artas System

- Pathway: 510(k) (Traditional)
- Applicant: Restoration Robotics, Inc.
- Decided: Feb 25, 2013 after 98 days
- Product code: ONA (Computer Assisted Hair Harvesting System)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 4 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 40 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.
- (no number) Recipient Site Blades: named in the summary without a submission number

## Most influential descendants
- K173358: ARTAS System (2018), 0 descendants of its own

## Recalls of this device
- Oct 13, 2013 · Class II · Z-0356-2014: Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation proc
- Oct 13, 2013 · Class II · Z-0354-2014: Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation proc
- Oct 13, 2013 · Class II · Z-0353-2014: Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation proc
- Oct 13, 2013 · Class II · Z-0355-2014: Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation proc

## 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. The ARTAS System is also indicated for creating recipient sites for subsequent manual implantation of the harvested follicles.

Source page: https://510kreport.com/device/K123548
Methodology: https://510kreport.com/methodology