Lightin System, Lightin, Lightin Generator— 510(k) K232177

Name: FDA 510(k) clearance K232177
Creator: U.S. Food and Drug Administration
Published: 2024-07-10

Substantially Equivalent

Solmedix Co., Ltd.

FDA 510(k) clearance K232177 for Lightin System, Lightin, Lightin Generator, Substantially Equivalent on 2024-07-10. Applicant: Solmedix Co., Ltd.. Device class: 1.

Clearance details

Applicant: Solmedix Co., Ltd.
Product code: Code SBS
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 2023-07-24
Decision date: 2024-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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