Diode laser device (BM091)
K-Number: K251801 · 2025-08-08
ApplicantHebei Newangie Technology Co., Ltd.
Decision Date2025-08-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Diode laser device (BM091) is a medical device manufactured by Hebei Newangie Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-08-08 under approval number K251801. 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 device (BM091)?
Diode laser device (BM091) is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Hebei Newangie Technology Co., Ltd.. The 510(k) number is K251801.
When was Diode laser device (BM091) approved by the FDA?
Diode laser device (BM091) received FDA 510(k) clearance on 2025-08-08, under approval number K251801.
What company makes Diode laser device (BM091)?
Diode laser device (BM091) is manufactured by Hebei Newangie Technology Co., Ltd..
What is the FDA product code for Diode laser device (BM091)?
The FDA product code for Diode laser device (BM091) is GEX. This falls under the Gastroenterology category.
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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.