K242293
- 510(k) number
- K242293
- Device name
- Medical Thulium Fiber Laser Systems (UroFiber 60Q)
- Applicant
- Rhein Laser Technologies Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-11-19
- Date received
- 2024-08-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K242293.pdf
Official FDA record: K242293
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.