510(k) K243854
K243854 is an FDA 510(k) premarket notification submitted by Contour Research, LLC for the device "Contour Light (CL-100)". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400. Contour Research, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2026
- Date Received
- December 16, 2024
- Clearance Type
- Special
- 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