ONA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Computer Assisted Hair Harvesting System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- FDA definition
- A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation.
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Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| ARTAS System (K173358) | Restoration Robotics, Inc. | 2018-03-16 | + Add |
| THE ARTAS SYSTEM (K123548) | Restoration Robotics, Inc. | 2013-02-25 | + Add |
| ARTAS SYSTEM FROM RESTORATION ROBOTICS (K123154) | Restoration Robotics, Inc. | 2013-02-19 | + Add |
| THE ARTAS SYSTEM FROM RESTORATION ROBOTICS (K103428) | Restoration Robotics, Inc. | 2011-04-04 | + Add |
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Every clearance here is in the API, with alerts when new ones post.