K261204
- 510(k) number
- K261204
- Device name
- Intense Pulsed Light Therapy Device
- Applicant
- Sanhe LEFIS Electronics Co., Ltd. CN
- Product code
- ONF — Powered Light Based Non-Laser Surgical Instrument Wi
- Decision date
- 2026-06-12
- Date received
- 2026-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K261204.pdf
Official FDA record: K261204
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.