510(k) K130283
K130283 is an FDA 510(k) premarket notification submitted by F Care Systems NV for the device "EVRF SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 7, 2013. The device falls under product code ONQ (Electrosurgical Coagulation For Aesthetic), a Class II device regulated under 21 CFR 878.4400.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 7, 2013
- Date Received
- Feb 5, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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.