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FDA 510(k)

Picosecond Nd:YAG Laser Systems (Model: HS-298)

K-Number: K260017 · 2026-04-09

ApplicantShanghai Apolo Medical Technology Co., Ltd.
Decision Date2026-04-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Picosecond Nd:YAG Laser Systems (Model: HS-298) is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under approval number K260017. 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 Nd:YAG Laser Systems (Model: HS-298)?

Picosecond Nd:YAG Laser Systems (Model: HS-298) is a medical device that received FDA 510(k) clearance on 2026-04-09. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K260017.

When was Picosecond Nd:YAG Laser Systems (Model: HS-298) approved by the FDA?

Picosecond Nd:YAG Laser Systems (Model: HS-298) received FDA 510(k) clearance on 2026-04-09, under approval number K260017.

What company makes Picosecond Nd:YAG Laser Systems (Model: HS-298)?

Picosecond Nd:YAG Laser Systems (Model: HS-298) is manufactured by Shanghai Apolo Medical Technology Co., Ltd..

What is the FDA product code for Picosecond Nd:YAG Laser Systems (Model: HS-298)?

The FDA product code for Picosecond Nd:YAG Laser Systems (Model: HS-298) is GEX. This falls under the Gastroenterology category.

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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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