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FDA 510(k)

Boston Pico755

K-Number: K252369 · 2026-01-21

ApplicantBoston Aesthetics, Inc.
Decision Date2026-01-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Boston Pico755 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2026-01-21 under 510(k) number K252369. 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 Boston Pico755?

Boston Pico755 is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K252369.

When did Boston Pico755 receive FDA 510(k) clearance?

Boston Pico755 received FDA 510(k) clearance on 2026-01-21, under 510(k) number K252369.

Who is the listed applicant for Boston Pico755?

The FDA 510(k) record lists Boston Aesthetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Boston Pico755?

The FDA product code for Boston Pico755 is GEX. This falls under the Gastroenterology category.

Other records listing Boston Aesthetics, Inc. 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.

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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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