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FDA 510(k)

Lightin System, Lightin, Lightin Generator

K-Number: K232177 · 2024-07-10

Decision Date2024-07-10
Product CodeSBS
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Lightin System, Lightin, Lightin Generator is the device name listed in this FDA 510(k) record. The listed applicant is Solmedix Co., Ltd.. It received FDA 510(k) clearance on 2024-07-10 under 510(k) number K232177. The device is classified under product code SBS. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lightin System, Lightin, Lightin Generator?

Lightin System, Lightin, Lightin Generator is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Solmedix Co., Ltd.. The 510(k) number is K232177.

When did Lightin System, Lightin, Lightin Generator receive FDA 510(k) clearance?

Lightin System, Lightin, Lightin Generator received FDA 510(k) clearance on 2024-07-10, under 510(k) number K232177.

Who is the listed applicant for Lightin System, Lightin, Lightin Generator?

The FDA 510(k) record lists Solmedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lightin System, Lightin, Lightin Generator?

The FDA product code for Lightin System, Lightin, Lightin Generator is SBS.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.