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FDA 510(k)

Diode Laser Machine, Model Number: BM-100

K-Number: K211335 · 2021-07-28

ApplicantZhengzhou Bestview ST Co., Ltd.
Decision Date2021-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Machine, Model Number: BM-100 is a medical device manufactured by Zhengzhou Bestview ST Co., Ltd.. It received FDA 510(k) clearance on 2021-07-28 under approval number K211335. 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 Diode Laser Machine, Model Number: BM-100?

Diode Laser Machine, Model Number: BM-100 is a medical device that received FDA 510(k) clearance on 2021-07-28. It is manufactured by Zhengzhou Bestview ST Co., Ltd.. The 510(k) number is K211335.

When was Diode Laser Machine, Model Number: BM-100 approved by the FDA?

Diode Laser Machine, Model Number: BM-100 received FDA 510(k) clearance on 2021-07-28, under approval number K211335.

What company makes Diode Laser Machine, Model Number: BM-100?

Diode Laser Machine, Model Number: BM-100 is manufactured by Zhengzhou Bestview ST Co., Ltd..

What is the FDA product code for Diode Laser Machine, Model Number: BM-100?

The FDA product code for Diode Laser Machine, Model Number: BM-100 is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41358283 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. medRxiv : the preprint server for health sciences (2025)

Other Devices by Zhengzhou Bestview ST Co., Ltd.

K211735CO2 Laser Machine, Model: BW-203B

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Official Source

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