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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 the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2025-04-24 under 510(k) 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. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K250206.

When did Diode laser system (Night Universe; Predator) receive FDA 510(k) clearance?

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

Who is the listed applicant for Diode laser system (Night Universe; Predator)?

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

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.

Other records listing Ivylaser (Beijing) Technology Co.,Ltd as applicant

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.

K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)K230025IVYLASER Handhold Hair Removal Machine

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.

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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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