THE ARTAS SYSTEM— 510(k) K123548

Clearance details

Applicant

Restoration Robotics, Inc.

Product code

Code ONA

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2012-11-19

Decision date

2013-02-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Josev, CA, US

• K173358 — ARTAS System2018-03-16
• K123154 — ARTAS SYSTEM FROM RESTORATION ROBOTICS2013-02-19
• K103428 — THE ARTAS SYSTEM FROM RESTORATION ROBOTICS2011-04-04

• Z-0353-2014 — Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.Class II·Terminated·Restoration Robotics·20131013
• Z-0354-2014 — ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267). RX. Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.Class II·Terminated·Restoration Robotics·20131013
• Z-0355-2014 — Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.Class II·Terminated·Restoration Robotics·20131013
• Z-0356-2014 — ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.Class II·Terminated·Restoration Robotics·20131013

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123548.