Neowise
K-Number: K260716 · 2026-05-04
ApplicantCefla S.C.
Decision Date2026-05-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Neowise is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2026-05-04 under approval number K260716. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neowise?
Neowise is a medical device that received FDA 510(k) clearance on 2026-05-04. It is manufactured by Cefla S.C.. The 510(k) number is K260716.
When was Neowise approved by the FDA?
Neowise received FDA 510(k) clearance on 2026-05-04, under approval number K260716.
What company makes Neowise?
Neowise is manufactured by Cefla S.C..
What is the FDA product code for Neowise?
The FDA product code for Neowise is LLZ.
Related Devices (Code: LLZ)
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.