510(k) K112334
K112334 is an FDA 510(k) premarket notification submitted by Refine USA, LLC for the device "VEIN-GOGH INSTRUMENT". The FDA issued a decision of Substantially Equivalent on May 8, 2012. The device falls under product code ONQ (Electrosurgical Coagulation For Aesthetic), a Class II device regulated under 21 CFR 878.4400. Refine USA, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2012
- Date Received
- Aug 12, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical Coagulation For Aesthetic
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
For the treatment of spider vein or telangiectasia by thermocoagulation.