AesyBite Active— 510(k) K260360

Substantially Equivalent

Aesyra SA

FDA 510(k) clearance K260360 for AesyBite Active, Substantially Equivalent on 2026-10-30. Applicant: Aesyra SA. Device class: 2.

Clearance details

Applicant: Aesyra SA
Product code: Product code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 2026-02-04
Decision date: 2026-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lausanne, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.