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FDA 510(k)

Boston PICO (Boston PICO)

K-Number: K251981 · 2026-01-30

ApplicantBoston Aesthetics, Inc.
Decision Date2026-01-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Boston PICO (Boston PICO) 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 2026-01-30 under 510(k) number K251981. 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 PICO (Boston PICO)?

Boston PICO (Boston PICO) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K251981.

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

Boston PICO (Boston PICO) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K251981.

Who is the listed applicant for Boston PICO (Boston PICO)?

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 PICO (Boston PICO)?

The FDA product code for Boston PICO (Boston PICO) 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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