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FDA 510(k)

Nd: YAG Laser Therapy Systems

K-Number: K260375 · 2026-03-31

ApplicantSanhe Meditech Co., Ltd.
Decision Date2026-03-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nd: YAG Laser Therapy Systems is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe Meditech Co., Ltd.. It received FDA 510(k) clearance on 2026-03-31 under 510(k) number K260375. 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 Nd: YAG Laser Therapy Systems?

Nd: YAG Laser Therapy Systems is a medical device that received FDA 510(k) clearance on 2026-03-31. The listed applicant is Sanhe Meditech Co., Ltd.. The 510(k) number is K260375.

When did Nd: YAG Laser Therapy Systems receive FDA 510(k) clearance?

Nd: YAG Laser Therapy Systems received FDA 510(k) clearance on 2026-03-31, under 510(k) number K260375.

Who is the listed applicant for Nd: YAG Laser Therapy Systems?

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

What is the FDA product code for Nd: YAG Laser Therapy Systems?

The FDA product code for Nd: YAG Laser Therapy Systems is GEX. This falls under the Gastroenterology category.

Other records listing Sanhe Meditech 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.

K260257CO2 Laser SystemK252427Diode Laser Hair Removal Machine (GLD01)

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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