510(k) K130341
K130341 is an FDA 510(k) premarket notification submitted by Laser Lipo Limited for the device "STRAWBERRY, STRAWBERRY & CREAM". The FDA issued a decision of Substantially Equivalent on Sep 6, 2013. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 6, 2013
- Date Received
- Feb 11, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Fat Reducing Low Level Laser
- Device Class
- Class II
- Regulation Number
- 878.5400
- Review Panel
- SU
- Submission Type
- 510(k)
Non-invasive reduction in fat layer for body contouring