510(k) K192275
K192275 is an FDA 510(k) premarket notification submitted by IR Technology, LLC for the device "invisa-RED ELITE". The FDA issued a decision of Substantially Equivalent on August 19, 2020. 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
- August 19, 2020
- Date Received
- August 22, 2019
- 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