ARTAS SYSTEM FROM RESTORATION ROBOTICS— 510(k) K123154

Name: FDA 510(k) clearance K123154
Creator: U.S. Food and Drug Administration
Published: 2013-02-19

Substantially Equivalent

Restoration Robotics, Inc.

FDA 510(k) clearance K123154 for ARTAS SYSTEM FROM RESTORATION ROBOTICS, Substantially Equivalent on 2013-02-19. Applicant: Restoration Robotics, Inc.. Device class: 2.

Clearance details

Applicant: Restoration Robotics, Inc.
Product code: Code ONA
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2012-10-09
Decision date: 2013-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Josev, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ONA

view all

K173358 — ARTAS System2018-03-16
K123548 — THE ARTAS SYSTEM2013-02-25
K103428 — THE ARTAS SYSTEM FROM RESTORATION ROBOTICS2011-04-04

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