Medi Lift Essential Eye Mask— 510(k) K250618

Substantially Equivalent

Ya-Man, Ltd.

FDA 510(k) clearance K250618 for Medi Lift Essential Eye Mask, Substantially Equivalent on 2025-10-29. Applicant: Ya-Man, Ltd.. Device class: 2.

Clearance details

Applicant: Ya-Man, Ltd.
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2025-02-28
Decision date: 2025-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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