Product code ONA— Neurology

ARTAS SYSTEM FROM RESTORATION ROBOTICS

Classification name: Computer Assisted Hair Harvesting System
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Total cleared: 4
First cleared: 2011-04-04
Most recent: 2018-03-16

FDA classification definition

“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.”
— U.S. Food and Drug Administration, device classification record for product code ONA under 21 CFR 882.4560, via openFDA

Market context for product code ONA

FDA has cleared 4 devices under product code ONA between 2011 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20181 clearance
20132 clearances
20111 clearance

Top applicants under product code ONA

Restoration Robotics, Inc.4 clearances

Recent clearances under product code ONA

K173358 — ARTAS SystemRestoration Robotics, Inc.·2018-03-16
K123548 — THE ARTAS SYSTEMRestoration Robotics, Inc.·2013-02-25
K123154 — ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.·2013-02-19
K103428 — THE ARTAS SYSTEM FROM RESTORATION ROBOTICSRestoration Robotics, Inc.·2011-04-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.