FDA 510(k)

PicoPeak Picosecond Nd:Yag Laser System (Bella-9)

K-Number: K262701 · 2026-10-22

ApplicantBeijing Sea Heart International Science and Technologyco.Ltd

Decision Date2026-10-22

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PicoPeak Picosecond Nd:Yag Laser System (Bella-9) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Sea Heart International Science and Technologyco.Ltd. It received FDA 510(k) clearance on 2026-10-22 under 510(k) number K262701. 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 PicoPeak Picosecond Nd:Yag Laser System (Bella-9)?

PicoPeak Picosecond Nd:Yag Laser System (Bella-9) is a medical device that received FDA 510(k) clearance on 2026-10-22. The listed applicant is Beijing Sea Heart International Science and Technologyco.Ltd. The 510(k) number is K262701.

When did PicoPeak Picosecond Nd:Yag Laser System (Bella-9) receive FDA 510(k) clearance?

PicoPeak Picosecond Nd:Yag Laser System (Bella-9) received FDA 510(k) clearance on 2026-10-22, under 510(k) number K262701.

Who is the listed applicant for PicoPeak Picosecond Nd:Yag Laser System (Bella-9)?

The FDA 510(k) record lists Beijing Sea Heart International Science and Technologyco.Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PicoPeak Picosecond Nd:Yag Laser System (Bella-9)?

The FDA product code for PicoPeak Picosecond Nd:Yag Laser System (Bella-9) is GEX. This falls under the Gastroenterology category.

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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.