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FDA 510(k)

Neowise

K-Number: K260716 · 2026-05-04

ApplicantCefla S.C.
Decision Date2026-05-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Neowise is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) 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. The listed applicant is Cefla S.C.. The 510(k) number is K260716.

When did Neowise receive FDA 510(k) clearance?

Neowise received FDA 510(k) clearance on 2026-05-04, under 510(k) number K260716.

Who is the listed applicant for Neowise?

The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neowise?

The FDA product code for Neowise is LLZ.

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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.

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