Cleared Traditional

K173358 - ARTAS System (FDA 510(k) Clearance)

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

K173358 · Restoration Robotics, Inc. · General & Plastic Surgery device
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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
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 114d · This submission: 142d
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.