THE ARTAS SYSTEM FROM RESTORATION ROBOTICS


Device Classification Name

computer assisted hair harvesting system

510(k) Number K103428
Device Name THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
Applicant
RESTORATION ROBOTICS, INC
155-a moffett park drive
suite 210
sunnyvale, 
CA 
94089

Applicant Contact kit cariquitan
Correspondent
RESTORATION ROBOTICS, INC
155-a moffett park drive
suite 210
sunnyvale, 
CA 
94089

Correspodent Contact kit cariquitan
Regulation Number 882.4560
Classification Product Code
ONA  
Date Received 11/22/2010
Decision Date 04/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Clinical Trials NCT00926211
Reviewed by Third Party No

Combination Product

No