FDA product code ONA: Computer Assisted Hair Harvesting System
ONA is the FDA product code for computer assisted hair harvesting system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under ONA. The average 510(k) review took 126 days (median 133). FDA has posted 4 recalls for ONA devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Computer Assisted Hair Harvesting System |
| Device class | Class II |
| Regulation | 21 CFR 882.4560 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for ONA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 142 |
Compare with all 510(k) review times · Search every ONA clearance
Top ONA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Restoration Robotics, Inc. | 4 | 2018-03-16 |
Most recent ONA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K173358 | Restoration Robotics, Inc. | ARTAS System | 2018-03-16 | 142 |
| K123548 | Restoration Robotics, Inc. | THE ARTAS SYSTEM | 2013-02-25 | 98 |
| K123154 | Restoration Robotics, Inc. | ARTAS SYSTEM FROM RESTORATION ROBOTICS | 2013-02-19 | 133 |
| K103428 | Restoration Robotics, Inc. | THE ARTAS SYSTEM FROM RESTORATION ROBOTICS | 2011-04-04 | 133 |
Recalls for ONA devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-10-13.
Frequently asked questions
What is FDA product code ONA?
ONA is the FDA product code for computer assisted hair harvesting system. It is a Class II device, regulated under 21 CFR 882.4560 and reviewed by the General and Plastic Surgery panel.
What device class is ONA?
Class II, regulation 21 CFR 882.4560. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONA?
Across 4 cleared submissions the average was 126 days from receipt to decision (median 133).
Which companies have the most ONA clearances?
Restoration Robotics, Inc. (4).
Have ONA devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2013-10-13.
Next steps
- Run an FDA pathway report with predicate devices for product code ONA
- Run a recall and safety report across every ONA manufacturer
- Watch product code ONA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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