YellowStar
K-Number: K261094 · 2026-04-29
ApplicantAsclepion Laser Technologies GmbH
Decision Date2026-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
YellowStar is a medical device manufactured by Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2026-04-29 under approval number K261094. 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 YellowStar?
YellowStar is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by Asclepion Laser Technologies GmbH. The 510(k) number is K261094.
When was YellowStar approved by the FDA?
YellowStar received FDA 510(k) clearance on 2026-04-29, under approval number K261094.
What company makes YellowStar?
YellowStar is manufactured by Asclepion Laser Technologies GmbH.
What is the FDA product code for YellowStar?
The FDA product code for YellowStar is GEX. This falls under the Gastroenterology category.
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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.