ONQ — Electrosurgical Coagulation For Aesthetic Class II

FDA Device Classification

FDA product code ONQ covers "Electrosurgical Coagulation For Aesthetic", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
ONQ
Device Class
Class II
Regulation Number
878.4400
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

For the treatment of spider vein or telangiectasia by thermocoagulation.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K210077F Care Systems UsaMED RF 4000Dec 17, 2021
K130283F Care SystemsEVRF SYSTEMMar 7, 2013
K112334Refine UsaVEIN-GOGH INSTRUMENTMay 8, 2012
K083352Newlands Clinical TrialsVEINWAVE, TC3000Jun 12, 2009