StarFormer
K-Number: K234061 · 2024-07-01
ApplicantFotona D.O.O.
Decision Date2024-07-01
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
StarFormer is a medical device manufactured by Fotona D.O.O.. It received FDA 510(k) clearance on 2024-07-01 under approval number K234061. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the StarFormer?
StarFormer is a medical device that received FDA 510(k) clearance on 2024-07-01. It is manufactured by Fotona D.O.O.. The 510(k) number is K234061.
When was StarFormer approved by the FDA?
StarFormer received FDA 510(k) clearance on 2024-07-01, under approval number K234061.
What company makes StarFormer?
StarFormer is manufactured by Fotona D.O.O..
What is the FDA product code for StarFormer?
The FDA product code for StarFormer is KPI.
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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.