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FDA 510(k)

Lasya-Trinity

K-Number: K241951 · 2024-10-10

ApplicantBLUECORE COMPANY Co., Ltd.
Decision Date2024-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lasya-Trinity is the device name listed in this FDA 510(k) record. The listed applicant is BLUECORE COMPANY Co., Ltd.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K241951. 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 Lasya-Trinity?

Lasya-Trinity is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is BLUECORE COMPANY Co., Ltd.. The 510(k) number is K241951.

When did Lasya-Trinity receive FDA 510(k) clearance?

Lasya-Trinity received FDA 510(k) clearance on 2024-10-10, under 510(k) number K241951.

Who is the listed applicant for Lasya-Trinity?

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

What is the FDA product code for Lasya-Trinity?

The FDA product code for Lasya-Trinity is GEX. This falls under the Gastroenterology category.

Other records listing BLUECORE COMPANY 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.

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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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