Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2026-01-30 under approval 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. It is manufactured by Boston Aesthetics, Inc.. The 510(k) number is K251981.

When was Boston PICO (Boston PICO) approved by the FDA?

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

What company makes Boston PICO (Boston PICO)?

Boston PICO (Boston PICO) is manufactured by Boston Aesthetics, Inc..

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 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) K252369Boston Pico755 K251988Boston iFace (Boston iFace)

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑