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FDA 510(k)

Diode laser system (Night Universe; Predator)

K-Number: K250206 · 2025-04-24

ApplicantIvylaser (Beijing) Technology Co.,Ltd
Decision Date2025-04-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode laser system (Night Universe; Predator) is a medical device manufactured by Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2025-04-24 under approval number K250206. 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 system (Night Universe; Predator)?

Diode laser system (Night Universe; Predator) is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K250206.

When was Diode laser system (Night Universe; Predator) approved by the FDA?

Diode laser system (Night Universe; Predator) received FDA 510(k) clearance on 2025-04-24, under approval number K250206.

What company makes Diode laser system (Night Universe; Predator)?

Diode laser system (Night Universe; Predator) is manufactured by Ivylaser (Beijing) Technology Co.,Ltd.

What is the FDA product code for Diode laser system (Night Universe; Predator)?

The FDA product code for Diode laser system (Night Universe; Predator) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other Devices by Ivylaser (Beijing) Technology Co.,Ltd

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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.

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