ONQ · Class II · 21 CFR 878.4400

FDA Product Code ONQ: Electrosurgical Coagulation For Aesthetic

For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation.

Leading manufacturers include F Care Systems USA, LLC.

4
Total
4
Cleared
213d
Avg days
2009
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Electrosurgical Coagulation For Aesthetic Devices (Product Code ONQ)

4 devices
1–4 of 4

About Product Code ONQ - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code ONQ since 2009, with 4 receiving FDA clearance (average review time: 213 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

ONQ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →