K261738
- 510(k) number
- K261738
- Device name
- Medical Thulium Fiber Laser Systems (UroFiber 150Q)
- Applicant
- Rhein Laser Technologies Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-07-21
- Date received
- 2026-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261738.pdf
Official FDA record: K261738
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.