The following data is part of a premarket notification filed by Restoration Robotics, Inc with the FDA for The Artas System From Restoration Robotics.
| Device ID | K103428 |
| 510k Number | K103428 |
| Device Name: | THE ARTAS SYSTEM FROM RESTORATION ROBOTICS |
| Classification | Computer Assisted Hair Harvesting System |
| Applicant | RESTORATION ROBOTICS, INC 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan RESTORATION ROBOTICS, INC 155-A MOFFETT PARK DRIVE SUITE 210 Sunnyvale, CA 94089 |
| Product Code | ONA |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850470007517 | K103428 | 000 |
| 00850470007371 | K103428 | 000 |
| 00850470007388 | K103428 | 000 |
| 00850470007395 | K103428 | 000 |
| 00850470007401 | K103428 | 000 |
| 00850470007425 | K103428 | 000 |
| 00850470007432 | K103428 | 000 |
| 00850470007449 | K103428 | 000 |
| 00850470007456 | K103428 | 000 |
| 00850470007463 | K103428 | 000 |
| 00850470007470 | K103428 | 000 |
| 00850470007487 | K103428 | 000 |
| 00850470007494 | K103428 | 000 |
| 00850470007500 | K103428 | 000 |
| 00850470007364 | K103428 | 000 |