FDA 510(k)

Boston Pico755

Número K: K252369 · 2026-01-21

Data da decisão2026-01-21

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Boston Aesthetics, Inc. como candidato(a)

K253245Boston 2910 (Boston 2910)K251981Boston PICO (Boston PICO)K251988Boston iFace (Boston iFace)K244022Sistema de Fototerapia UV de 308nm (UV-K); Sistema de Fototerapia UV de 308nm (UV-X); Sistema de Fototerapia UV de 308nm (UV-Y); Sistema de Fototerapia UV de 308nm (UV-Z)K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III)

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