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FDA 510(k)

Nd: YAG Laser Therapy Systems HM-YL900

K-Number: K202758 · 2020-11-16

ApplicantShangdong Huamei Technology Co., Ltd.
Decision Date2020-11-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nd: YAG Laser Therapy Systems HM-YL900 is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-11-16 under 510(k) number K202758. 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 Laser Therapy Systems HM-YL900?

Nd: YAG Laser Therapy Systems HM-YL900 is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K202758.

When did Nd: YAG Laser Therapy Systems HM-YL900 receive FDA 510(k) clearance?

Nd: YAG Laser Therapy Systems HM-YL900 received FDA 510(k) clearance on 2020-11-16, under 510(k) number K202758.

Who is the listed applicant for Nd: YAG Laser Therapy Systems HM-YL900?

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

What is the FDA product code for Nd: YAG Laser Therapy Systems HM-YL900?

The FDA product code for Nd: YAG Laser Therapy Systems HM-YL900 is GEX. This falls under the Gastroenterology category.

Other records listing Shangdong Huamei Technology Co., Ltd. as applicant

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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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.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.

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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