FDA product code ONQ: Electrosurgical Coagulation For Aesthetic
ONQ is the FDA product code for electrosurgical coagulation for aesthetic. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under ONQ, from 4 different applicants. The average 510(k) review took 212 days (median 240).
Definition
For the treatment of spider vein or telangiectasia by thermocoagulation.
Classification
| Field | Value |
|---|---|
| Device name | Electrosurgical Coagulation For Aesthetic |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ONQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 339 |
Compare with all 510(k) review times · Search every ONQ clearance
Top ONQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| F Care Systems USA, LLC | 1 | 2021-12-17 |
| F Care Systems NV | 1 | 2013-03-07 |
| Refine USA, LLC | 1 | 2012-05-08 |
| Newlands Clinical Trials, Ltd. | 1 | 2009-06-12 |
Most recent ONQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210077 | F Care Systems USA, LLC | MED RF 4000 | 2021-12-17 | 339 |
| K130283 | F Care Systems NV | EVRF SYSTEM | 2013-03-07 | 30 |
| K112334 | Refine USA, LLC | VEIN-GOGH INSTRUMENT | 2012-05-08 | 270 |
| K083352 | Newlands Clinical Trials, Ltd. | VEINWAVE, TC3000 | 2009-06-12 | 211 |
Recalls for ONQ devices
openFDA lists no recalls for product code ONQ.
Frequently asked questions
What is FDA product code ONQ?
ONQ is the FDA product code for electrosurgical coagulation for aesthetic. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is ONQ?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONQ?
Across 4 cleared submissions the average was 212 days from receipt to decision (median 240).
Which companies have the most ONQ clearances?
F Care Systems USA, LLC (1); F Care Systems NV (1); Refine USA, LLC (1); Newlands Clinical Trials, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ONQ
- Run a recall and safety report across every ONQ manufacturer
- Watch product code ONQ 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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