CoreLevee— 510(k) K213748

Substantially Equivalent

Lutronic Corporation

FDA 510(k) clearance K213748 for CoreLevee, Substantially Equivalent on 2022-10-14. Applicant: Lutronic Corporation. Device class: 2.

Clearance details

Applicant: Lutronic Corporation
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2021-11-30
Decision date: 2022-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deogyang-Gu, Goyang-Si, 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.