StarFormer, TightWave
K-Number: K221274 · 2023-09-29
ApplicantFotona D.O.O.
Decision Date2023-09-29
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
StarFormer, TightWave is a medical device manufactured by Fotona D.O.O.. It received FDA 510(k) clearance on 2023-09-29 under approval number K221274. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the StarFormer, TightWave?
StarFormer, TightWave is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Fotona D.O.O.. The 510(k) number is K221274.
When was StarFormer, TightWave approved by the FDA?
StarFormer, TightWave received FDA 510(k) clearance on 2023-09-29, under approval number K221274.
What company makes StarFormer, TightWave?
StarFormer, TightWave is manufactured by Fotona D.O.O..
What is the FDA product code for StarFormer, TightWave?
The FDA product code for StarFormer, TightWave is IPF.
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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.