510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONQClass II

Electrosurgical Coagulation For Aesthetic

21 CFR 878.4400 / General, Plastic Surgery
FDA source (opens on fda.gov)

ONQ is the FDA product code for Electrosurgical Coagulation For Aesthetic, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "For the treatment of spider vein or telangiectasia by thermocoagulation". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ONQ
Device name
Electrosurgical Coagulation For Aesthetic
FDA definition
For the treatment of spider vein or telangiectasia by thermocoagulation.
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code ONQ

By decision year
4 clearances under product code ONQ with a decision year between 2009 and 2021, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ONQ by decision year
YearClearances
20091
20121
20131
20211

Applicants with the most clearances

Product code ONQ
Applicants holding the most 510(k) clearances under product code ONQ
ApplicantClearances
F Care Systems NV1
F Care Systems USA1
Newlands Clinical Trials, Ltd.1
Refine USA, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code