K260688
- 510(k) number
- K260688
- Device name
- Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd. CN
- Product code
- OLI — Fat Reducing Low Level Laser
- Decision date
- 2026-05-04
- Date received
- 2026-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260688.pdf
Official FDA record: K260688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.