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FDA 510(k)

Silk’n Toothwave

K-Number: K214078 · 2023-01-13

ApplicantHome Skinovations , Ltd.
Decision Date2023-01-13
Product CodeQMJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Silk’n Toothwave is the device name listed in this FDA 510(k) record. The listed applicant is Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K214078. The device is classified under product code QMJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silk’n Toothwave?

Silk’n Toothwave is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K214078.

When did Silk’n Toothwave receive FDA 510(k) clearance?

Silk’n Toothwave received FDA 510(k) clearance on 2023-01-13, under 510(k) number K214078.

Who is the listed applicant for Silk’n Toothwave?

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

What is the FDA product code for Silk’n Toothwave?

The FDA product code for Silk’n Toothwave is QMJ.

Other records listing Home Skinovations , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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