510(k) K231474
K231474 is an FDA 510(k) premarket notification submitted by Erchonia Corporation for the device "Erchonia Violet ZERONA® Z6 OTC". The FDA issued a decision of Substantially Equivalent on July 21, 2023. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400. Erchonia Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2023
- Date Received
- May 22, 2023
- 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
Non-invasive reduction in fat layer for body contouring