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FDA 510(k)

Skin Air Cooling System (QALF-01)

K-Number: K261674 · 2026-07-16

ApplicantBeijing Nubway S&T Co., Ltd.
Decision Date2026-07-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Skin Air Cooling System (QALF-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 2026-07-16 under 510(k) number K261674. 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 Skin Air Cooling System (QALF-01)?

Skin Air Cooling System (QALF-01) is a medical device that received FDA 510(k) clearance on 2026-07-16. The listed applicant is Beijing Nubway S&T Co., Ltd.. The 510(k) number is K261674.

When did Skin Air Cooling System (QALF-01) receive FDA 510(k) clearance?

Skin Air Cooling System (QALF-01) received FDA 510(k) clearance on 2026-07-16, under 510(k) number K261674.

Who is the listed applicant for Skin Air Cooling System (QALF-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 Skin Air Cooling System (QALF-01)?

The FDA product code for Skin Air Cooling System (QALF-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)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.

K261693Diode laser hair removal machine (QDTM-04)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, LLCK260690LumiGlam Laser System (SHE-LSP601-3)Beijing Sano Laser S&T Development Co.,LtdK260489LASEmaR 1500Eufoton S.R.L.K260138LUNE PureHygieneEnamel Pure

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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