Medical Thulium Fiber Laser Systems (UroFiber 150Q)— 510(k) K261738
Substantially EquivalentRhein Laser Technologies Co., Ltd.
FDA 510(k) clearance K261738 for Medical Thulium Fiber Laser Systems (UroFiber 150Q), Substantially Equivalent on 2026-07-21. 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 all- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
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- K261570 — PICOSURE WORKSTATION
More 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.