510(k) Report

FDA applicant

Restoration Robotics, Inc.

San Josev, CA4 decisions2011–20184 recalls

FDA records 4 decisions for Restoration Robotics, Inc. (San Josev, CA) from 2011 to 2018: 4 510(k) clearances. All are in product code ONA (Computer Assisted Hair Harvesting System). Its devices cite 5 predicates, 3 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Restoration Robotics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2011: 12013: 22018: 1
2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

4in 2013

2013: 4
2011high 4 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Restoration Robotics, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Restoration Robotics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ONAComputer Assisted Hair Harvesting System4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc. · 20112cite it
  • K123548The Artas SystemRestoration Robotics, Inc. · 20131cites it

What has FDA decided for it lately?

  • K173358ARTAS SystemRestoration Robotics, Inc. · 2018
  • K123548The Artas SystemRestoration Robotics, Inc. · 20134 recalls
  • K123154Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2013
  • K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2011

All 4 as Restoration Robotics, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K123548ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with…Oct 13, 2013Class II
  • K123548ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube…Oct 13, 2013Class II
  • K123548Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using…Oct 13, 2013Class II
  • K123548Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly…Oct 13, 2013Class II