510(k) DEN090008
DEN090008 is an FDA 510(k) premarket notification submitted by Erchonia Medical for the device "ERCHONIA ML SCANNER (MLS)". The FDA issued a decision of De Novo Granted on August 24, 2010. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400. Erchonia Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 24, 2010
- Date Received
- January 5, 2009
- Clearance Type
- Post-NSE
- 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
Non-invasive reduction in fat layer for body contouring