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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 a medical device manufactured by Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2026-01-21 under approval 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. It is manufactured by Boston Aesthetics, Inc.. The 510(k) number is K252369.

When was Boston Pico755 approved by the FDA?

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

What company makes Boston Pico755?

Boston Pico755 is manufactured by Boston Aesthetics, Inc..

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 Devices by Boston Aesthetics, Inc.

K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) K251981Boston PICO (Boston PICO) K251988Boston iFace (Boston iFace)

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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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