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FDA 510(k)

PICOSURE WORKSTATION

K-Number: K261570 · 2026-06-17

ApplicantCynosure, LLC
Decision Date2026-06-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICOSURE WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, LLC. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K261570. 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 PICOSURE WORKSTATION?

PICOSURE WORKSTATION is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Cynosure, LLC. The 510(k) number is K261570.

When did PICOSURE WORKSTATION receive FDA 510(k) clearance?

PICOSURE WORKSTATION received FDA 510(k) clearance on 2026-06-17, under 510(k) number K261570.

Who is the listed applicant for PICOSURE WORKSTATION?

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

What is the FDA product code for PICOSURE WORKSTATION?

The FDA product code for PICOSURE WORKSTATION is GEX. This falls under the Gastroenterology category.

Other records listing Cynosure, LLC as applicant

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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.

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