Bluemoon— 510(k) K242386

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K242386 for Bluemoon, Substantially Equivalent on 2025-05-05. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2024-08-12
Decision date: 2025-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, CN

Download summary PDF View on FDA.gov ↗

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