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FDA 510(k)

Picosecond Laser treatment system (Z180)

K-Number: K262628 · 2026-10-20

ApplicantSanhe PERFECTLASER Technology Co., Ltd.
Decision Date2026-10-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picosecond Laser treatment system (Z180) is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe PERFECTLASER Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-10-20 under 510(k) number K262628. 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 Picosecond Laser treatment system (Z180)?

Picosecond Laser treatment system (Z180) is a medical device that received FDA 510(k) clearance on 2026-10-20. The listed applicant is Sanhe PERFECTLASER Technology Co., Ltd.. The 510(k) number is K262628.

When did Picosecond Laser treatment system (Z180) receive FDA 510(k) clearance?

Picosecond Laser treatment system (Z180) received FDA 510(k) clearance on 2026-10-20, under 510(k) number K262628.

Who is the listed applicant for Picosecond Laser treatment system (Z180)?

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

What is the FDA product code for Picosecond Laser treatment system (Z180)?

The FDA product code for Picosecond Laser treatment system (Z180) 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

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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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