FDA 510(k) ClearanceGEX
Medical Thulium Fiber Laser Systems (UroFiber 150Q)
FDA 510(k) K261738 · Rhein Laser Technologies Co., Ltd.
- 510(k) number
- K261738
- Device name
- Medical Thulium Fiber Laser Systems (UroFiber 150Q)
- Applicant
- Rhein Laser Technologies Co., Ltd.
- Product code
- GEX
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 878.4810
- Advisory committee
- SU
- Medical specialty
- General, Plastic Surgery
Candidate predicate devices
Other devices cleared under product code GEX form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261221 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) | Olympus Surgical Technologies America | |
| K261693 | Diode laser hair removal machine (QDTM-04) | Beijing Nubway S&T Co., Ltd. | |
| K261674 | Skin Air Cooling System (QALF-01) | Beijing Nubway S&T Co., Ltd. | |
| K261701 | Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) | Micro-Energy Medical Technology Co., Ltd. | |
| K261570 | PICOSURE WORKSTATION | Cynosure, LLC | |
| K260690 | LumiGlam Laser System (SHE-LSP601-3) | Beijing Sano Laser S&T Development Co.,Ltd | |
| K260138 | LUNE PureHygiene | Enamel Pure | |
| K260489 | LASEmaR 1500 | Eufoton S.R.L. | |
| K253245 | Boston 2910 (Boston 2910) | Boston Aesthetics, Inc. | |
| K260100 | MOSES Raydar™ | Boston Scientific Corporation | |
| K261214 | PICO SHINING (PICO-K; PICOFY) | Speclipse, Inc. |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.