StarFormer (M008-3T)
K-Number: K241785 · 2025-03-27
ApplicantFotona D.O.O.
Decision Date2025-03-27
Product CodeQPL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
StarFormer (M008-3T) is a medical device manufactured by Fotona D.O.O.. It received FDA 510(k) clearance on 2025-03-27 under approval number K241785. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the StarFormer (M008-3T)?
StarFormer (M008-3T) is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Fotona D.O.O.. The 510(k) number is K241785.
When was StarFormer (M008-3T) approved by the FDA?
StarFormer (M008-3T) received FDA 510(k) clearance on 2025-03-27, under approval number K241785.
What company makes StarFormer (M008-3T)?
StarFormer (M008-3T) is manufactured by Fotona D.O.O..
What is the FDA product code for StarFormer (M008-3T)?
The FDA product code for StarFormer (M008-3T) is QPL.
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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.