510(k) K083352
K083352 is an FDA 510(k) premarket notification submitted by Newlands Clinical Trials, Ltd. for the device "VEINWAVE, TC3000". The FDA issued a decision of Substantially Equivalent on Jun 12, 2009. 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
- Jun 12, 2009
- Date Received
- Nov 13, 2008
- 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.