ARTAS SYSTEM FROM RESTORATION ROBOTICS
FDA 510(k) clearance K123154 · decided 2013-02-19
Clearance details
- K-number
- K123154
- Device name
- ARTAS SYSTEM FROM RESTORATION ROBOTICS
- Applicant
- Restoration Robotics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-09
- Decision date
- 2013-02-19
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- ONA
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Josev, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Restoration Robotics
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTAS System (K173358) | Restoration Robotics, Inc. | 2018-03-16 |
| THE ARTAS SYSTEM (K123548) | Restoration Robotics, Inc. | 2013-02-25 |
| THE ARTAS SYSTEM FROM RESTORATION ROBOTICS (K103428) | Restoration Robotics, Inc. | 2011-04-04 |
Recalls involving this device
No recalls on record reference this clearance.