Cleared Traditional

K173358 - ARTAS System

K173358 is the FDA 510(k) clearance for ARTAS System by Restoration Robotics, Inc.. It is a Class 2 General & Plastic Surgery device (product code ONA) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K173358 · Restoration Robotics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
142d
Days
Class 2
Risk

K173358 is an FDA 510(k) clearance for the ARTAS System. Classified as Computer Assisted Hair Harvesting System (product code ONA), Class II - Special Controls.

Submitted by Restoration Robotics, Inc. (San Josev, US). The FDA issued a Cleared decision on March 16, 2018 after a review of 142 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.4560 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Restoration Robotics, Inc. devices

Submission Details

510(k) Number K173358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2017
Decision Date March 16, 2018
Days to Decision 142 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ONA Computer Assisted Hair Harvesting System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02914587 Unknown Interventional Industry-sponsored

Computer-Assisted Hair Implantation Using ARTAS System VS Manual Implantation Technique Hair Restoration Study

32
Patients (actual)
1
Site
Treatment
Purpose
Single blind
Masking
Condition studied Androgenic Alopecia
Study design Crossover
Eligibility Male only · 29 Years+
Sponsor Restoration Robotics, Inc. (industry)
Started 2016-08-01 → Primary completion 2017-10-01
Primary outcome
Hair Survival rate 9-months post procedure
View full study on ClinicalTrials.gov