ONA · Class II · 21 CFR 882.4560

FDA Product Code ONA: Computer Assisted Hair Harvesting System

A Computer Assisted Harvesting System Used In Identifying And Extracting Hair Follicular Units And Indicated To Assist Surgeon In Identifying And Extracting Hair Follicular Units During Hair Transplantation.

Leading manufacturers include Restoration Robotics, Inc..

4
Total
4
Cleared
127d
Avg days
2011
Since

FDA 510(k) Cleared Computer Assisted Hair Harvesting System Devices (Product Code ONA)

4 devices
1–4 of 4
Cleared Mar 16, 2018
ARTAS System
K173358
Restoration Robotics, Inc.
General & Plastic Surgery · 142d
Cleared Feb 25, 2013
THE ARTAS SYSTEM
K123548
Restoration Robotics, Inc.
General & Plastic Surgery · 98d
Cleared Feb 19, 2013
ARTAS SYSTEM FROM RESTORATION ROBOTICS
K123154
Restoration Robotics, Inc.
General & Plastic Surgery · 133d
Cleared Apr 04, 2011
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
K103428
Restoration Robotics, Inc.
General & Plastic Surgery · 133d

About Product Code ONA - Regulatory Context