Restoration Robotics

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0353-2014Class IIEpsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; October 13, 2013
Z-0355-2014Class IISterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; NOctober 13, 2013
Z-0354-2014Class IIARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; DisOctober 13, 2013
Z-0356-2014Class IIARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum TOctober 13, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K173358ARTAS SystemMarch 16, 2018
K123548THE ARTAS SYSTEMFebruary 25, 2013
K123154ARTAS SYSTEM FROM RESTORATION ROBOTICSFebruary 19, 2013
K103428THE ARTAS SYSTEM FROM RESTORATION ROBOTICSApril 4, 2011