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FDA 510(k)

Vatech Clismile

K-Number: K220689 · 2022-05-06

ApplicantRayence Co., Ltd.
Decision Date2022-05-06
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vatech Clismile is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K220689. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vatech Clismile?

Vatech Clismile is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K220689.

When did Vatech Clismile receive FDA 510(k) clearance?

Vatech Clismile received FDA 510(k) clearance on 2022-05-06, under 510(k) number K220689.

Who is the listed applicant for Vatech Clismile?

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

What is the FDA product code for Vatech Clismile?

The FDA product code for Vatech Clismile is NJM.

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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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