The following data is part of a premarket notification filed by Restoration Robotics, Inc with the FDA for The Artas System.
| Device ID | K123548 |
| 510k Number | K123548 |
| Device Name: | THE ARTAS SYSTEM |
| Classification | Computer Assisted Hair Harvesting System |
| Applicant | RESTORATION ROBOTICS, INC 128 BAYTECH DRIVE San Jose, CA 95134 |
| Contact | Jim Talbot |
| Correspondent | Jim Talbot RESTORATION ROBOTICS, INC 128 BAYTECH DRIVE San Jose, CA 95134 |
| Product Code | ONA |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2013-02-25 |
| Summary: | summary |