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FDA 510(k)

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)

K-Number: K251464 · 2025-10-03

ApplicantJeisys Medical Incorporated
Decision Date2025-10-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K251464. 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 TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K251464.

When did TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) receive FDA 510(k) clearance?

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K251464.

Who is the listed applicant for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

The FDA 510(k) record lists Jeisys Medical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

The FDA product code for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is GEX. This falls under the Gastroenterology category.

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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

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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