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FDA 510(k)

Plasonic (Plasonic)

K-Number: K241099 · 2024-11-08

ApplicantHironic Co., Ltd.
Decision Date2024-11-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plasonic (Plasonic) is the device name listed in this FDA 510(k) record. The listed applicant is Hironic Co., Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K241099. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Plasonic (Plasonic)?

Plasonic (Plasonic) is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Hironic Co., Ltd.. The 510(k) number is K241099.

When did Plasonic (Plasonic) receive FDA 510(k) clearance?

Plasonic (Plasonic) received FDA 510(k) clearance on 2024-11-08, under 510(k) number K241099.

Who is the listed applicant for Plasonic (Plasonic)?

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

What is the FDA product code for Plasonic (Plasonic)?

The FDA product code for Plasonic (Plasonic) is GEI.

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Official Source

View on FDA Database →

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

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