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FDA 510(k)

Q Switched Nd:YAG Laser machine (QLQW-01)

K-Number: K261841 · 2026-08-11

ApplicantBeijing Nubway S&T Co., Ltd.
Decision Date2026-08-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q Switched Nd:YAG Laser machine (QLQW-01) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Nubway S&T Co., Ltd.. It received FDA 510(k) clearance on 2026-08-11 under 510(k) number K261841. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q Switched Nd:YAG Laser machine (QLQW-01)?

Q Switched Nd:YAG Laser machine (QLQW-01) is a medical device that received FDA 510(k) clearance on 2026-08-11. The listed applicant is Beijing Nubway S&T Co., Ltd.. The 510(k) number is K261841.

When did Q Switched Nd:YAG Laser machine (QLQW-01) receive FDA 510(k) clearance?

Q Switched Nd:YAG Laser machine (QLQW-01) received FDA 510(k) clearance on 2026-08-11, under 510(k) number K261841.

Who is the listed applicant for Q Switched Nd:YAG Laser machine (QLQW-01)?

The FDA 510(k) record lists Beijing Nubway S&T Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q Switched Nd:YAG Laser machine (QLQW-01)?

The FDA product code for Q Switched Nd:YAG Laser machine (QLQW-01) is GEX. This falls under the Gastroenterology category.

Other records listing Beijing Nubway S&T Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261693Diode laser hair removal machine (QDTM-04)K261674Skin Air Cooling System (QALF-01)K242951Diode laser hair removal machine (QDTM-02)K242943Q Switched Nd:YAG Laser machine (QNHF-01)

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase 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.K261570PICOSURE WORKSTATIONCynosure, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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