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 Newlands Clinical Trials, Ltd., Refine USA, LLC and F Care Systems NV.

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
Cleared Dec 17, 2021
MED RF 4000
K210077
F Care Systems USA, LLC
General & Plastic Surgery · 339d
Cleared Mar 07, 2013
EVRF SYSTEM
K130283
F Care Systems NV
General & Plastic Surgery · 30d
Cleared May 08, 2012
VEIN-GOGH INSTRUMENT
K112334
Refine USA, LLC
General & Plastic Surgery · 270d
Cleared Jun 12, 2009
VEINWAVE, TC3000
K083352
Newlands Clinical Trials, Ltd.
General & Plastic Surgery · 211d

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.