510(k) K071872
K071872 is an FDA 510(k) premarket notification submitted by Syneron Medical, Ltd. for the device "VELASHAPE". The FDA issued a decision of Substantially Equivalent on August 22, 2007. The device falls under product code NUV (Massager, Vacuum, Light Induced Heating), a Class II device regulated under 21 CFR 878.4810. Syneron Medical, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2007
- Date Received
- July 6, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Vacuum, Light Induced Heating
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
The device is intended to temporarily alter the appearance of cellulite