eCO2 3D— 510(k) K244060

Substantially Equivalent

Lutronic Corporation

FDA 510(k) clearance K244060 for eCO2 3D, Substantially Equivalent on 2025-07-31. Applicant: Lutronic Corporation. Device class: 2.

Clearance details

Applicant: Lutronic Corporation
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2024-12-31
Decision date: 2025-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deogyang-Gu, 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.