LED Therapy Device (QLXY-01)— 510(k) K261673
Substantially EquivalentBeijing Nubway S&T Co., Ltd.
FDA 510(k) clearance K261673 for LED Therapy Device (QLXY-01), Substantially Equivalent on 2026-09-17. Applicant: Beijing Nubway S&T Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Beijing Nubway S&T 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
- Beijing, CN
Recent devices under product code GEX
view all- K241973 — SmartIPL_NI System
- K252723 — Dynamis Pro Family
- K261047 — Dental Diode Laser Device (Laser-Pen)
- K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
- K262877 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
More clearances from Beijing Nubway S&T 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.