510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112334Substantially Equivalent

Vein-Gogh Instrument

Refine USA, LLC, Jacksonville Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112334 is the FDA 510(k) clearance record for VEIN-GOGH INSTRUMENT, a class II device, cleared for Refine USA, LLC on under FDA product code ONQ (Electrosurgical Coagulation For Aesthetic). FDA's definition for product code ONQ reads: "For the treatment of spider vein or telangiectasia by thermocoagulation". FDA records list 2 510(k) clearances for Refine USA, LLC, from to . As of , FDA records show no recalls naming K112334.

Clearance record

Decision date
Received
(270 days to decision)
Product code
ONQ Electrosurgical Coagulation For Aesthetic
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Refine USA, LLC 340 3rd Ave. S. Suite C, Jacksonville Beach FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONQ

Trailing 12 months

FDA records hold no clearances under product code ONQ in the trailing twelve months.

FDA records show no clearances under product code ONQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260