The following data is part of a premarket notification filed by Restoration Robotics, Inc. with the FDA for Artas System.
| Device ID | K173358 |
| 510k Number | K173358 |
| Device Name: | ARTAS System |
| Classification | Computer Assisted Hair Harvesting System |
| Applicant | Restoration Robotics, Inc. 128 Baytech Drive San Jose, CA 95134 |
| Contact | Raymond Lee |
| Correspondent | Raymond Lee 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 | 2017-10-25 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850470007630 | K173358 | 000 |
| 00850470007623 | K173358 | 000 |
| 00850470007579 | K173358 | 000 |
| 00850470007562 | K173358 | 000 |
| 00850470007531 | K173358 | 000 |
| 00850470007524 | K173358 | 000 |
| 00810060831632 | K173358 | 000 |