SMILE— 510(k) K213629

Substantially Equivalent

Nu Eyne Co., Ltd.

FDA 510(k) clearance K213629 for SMILE, Substantially Equivalent on 2023-02-12. Applicant: Nu Eyne Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nu Eyne Co., Ltd.
Product code: Code QGL
Device class: Class 2
Regulation: 21 CFR 882.5898
Advisory panel: Neurology
Date received: 2021-11-17
Decision date: 2023-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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