Cleared Traditional

K103428 - THE ARTAS SYSTEM FROM RESTORATION ROBOTICS

K103428 is an FDA 510(k) clearance for THE ARTAS SYSTEM FROM RESTORATION ROBOTICS, manufactured by Restoration Robotics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code ONA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K103428 · Restoration Robotics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
133d
Days
Class 2
Risk

K103428 is an FDA 510(k) clearance for the THE ARTAS SYSTEM FROM RESTORATION ROBOTICS. Classified as Computer Assisted Hair Harvesting System (product code ONA), Class II - Special Controls.

Submitted by Restoration Robotics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 4, 2011 after a review of 133 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

FDA 510(k) Submission Details - K103428

510(k) Number K103428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date April 04, 2011
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

ONA Device Classification - Class 2, Special Controls

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
NCT00926211 Completed Interventional Industry-sponsored

Computer-Assisted Versus Manual Hair Harvest Comparative Study

Safety and Efficacy of Computer-Assisted vs. Manual Hair Follicle Harvest: A Comparative Hair Count Study

37
Patients (actual)
2
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Androgenetic Alopecia
Study design Parallel
Eligibility Male only · 30 Years+ · Healthy volunteers accepted
Principal investigator Miguel Canales, M.D.
Sponsor Restoration Robotics, Inc. (industry)
Started 2009-06-01 → Primary completion 2010-09-01
Primary outcome
Increase in Hair Follicles Present
Secondary outcome
Proportion of Harvested Follicles Transected
View full study on ClinicalTrials.gov