K112334 is an FDA 510(k) clearance for the VEIN-GOGH INSTRUMENT. This device is classified as a Electrosurgical Coagulation For Aesthetic (Class II - Special Controls, product code ONQ).
Submitted by Refine USA, LLC (Jacksonville Beach, US). The FDA issued a Cleared decision on May 8, 2012, 270 days after receiving the submission on August 12, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation..
| 510(k) Number | K112334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2011 |
| Decision Date | May 08, 2012 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ONQ - Electrosurgical Coagulation For Aesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | For The Treatment Of Spider Vein Or Telangiectasia By Thermocoagulation. |