Medical Thulium Fiber Laser Systems (UroFiber 60Q)— 510(k) K242293
Substantially EquivalentRhein Laser Technologies Co., Ltd.
FDA 510(k) clearance K242293 for Medical Thulium Fiber Laser Systems (UroFiber 60Q), Substantially Equivalent on 2024-11-19. Applicant: Rhein Laser Technologies Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Rhein Laser Technologies Co., Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuhan, CN
Recent devices under product code GEX
view allMore clearances from Rhein Laser Technologies Co., Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.