DeviceClearance

Product code ONQ— General, Plastic Surgery

EVRF SYSTEM

Classification name
Electrosurgical Coagulation For Aesthetic
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

FDA classification definition

“For the treatment of spider vein or telangiectasia by thermocoagulation.”

— U.S. Food and Drug Administration, device classification record for product code ONQ under 21 CFR 878.4400, via openFDA

Market context for product code ONQ

FDA has cleared 4 devices under product code ONQ between 2009 and 2021, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ONQ

Recent clearances under product code ONQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.