510(k) K260688
K260688 is an FDA 510(k) premarket notification submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. for the device "Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)". The FDA issued a decision of Substantially Equivalent on May 4, 2026. The device falls under product code OLI (Fat Reducing Low Level Laser), a Class II device regulated under 21 CFR 878.5400. Shenzhen Kaiyan Medical Equipment Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2026
- Date Received
- March 3, 2026
- 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