Device Classification Name |
Computer Assisted Hair Harvesting System
|
510(k) Number |
K173358 |
Device Name |
ARTAS System |
Applicant |
Restoration Robotics, Inc. |
128 Baytech Drive |
San Jose,
CA
95134
|
|
Applicant Contact |
Raymond Lee |
Correspondent |
Restoration Robotics, Inc. |
128 Baytech Drive |
San Jose,
CA
95134
|
|
Correspondent Contact |
Raymond Lee |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 10/25/2017 |
Decision Date | 03/16/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02914587
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|