Cleared Traditional

K103428 - THE ARTAS SYSTEM FROM RESTORATION ROBOTICS (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K103428 · Restoration Robotics, Inc. · General & Plastic Surgery device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 114d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.