ONA — Computer Assisted Hair Harvesting System Class II
FDA product code ONA covers "Computer Assisted Hair Harvesting System", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ONA
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K173358 | restoration robotics | ARTAS System | March 16, 2018 |
| K123548 | restoration robotics | THE ARTAS SYSTEM | February 25, 2013 |
| K123154 | restoration robotics | ARTAS SYSTEM FROM RESTORATION ROBOTICS | February 19, 2013 |
| K103428 | restoration robotics | THE ARTAS SYSTEM FROM RESTORATION ROBOTICS | April 4, 2011 |