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FDA 510(k)

Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)

K-Number: K261572 · 2026-10-13

ApplicantKeyue (Hangzhou) Medical Information Technology Co., Ltd.
Decision Date2026-10-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) is the device name listed in this FDA 510(k) record. The listed applicant is Keyue (Hangzhou) Medical Information Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-10-13 under 510(k) number K261572. 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 Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)?

Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) is a medical device that received FDA 510(k) clearance on 2026-10-13. The listed applicant is Keyue (Hangzhou) Medical Information Technology Co., Ltd.. The 510(k) number is K261572.

When did Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) receive FDA 510(k) clearance?

Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) received FDA 510(k) clearance on 2026-10-13, under 510(k) number K261572.

Who is the listed applicant for Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)?

The FDA 510(k) record lists Keyue (Hangzhou) Medical Information Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)?

The FDA product code for Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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.

K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)Wuhan Phomed Technology Co., Ltd.K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd.K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.

Official Source

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

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