Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2023-01-13 under approval 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. It is manufactured by Home Skinovations , Ltd.. The 510(k) number is K214078.

When was Silk’n Toothwave approved by the FDA?

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

What company makes Silk’n Toothwave?

Silk’n Toothwave is manufactured by Home Skinovations , Ltd..

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

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

Other Devices by Home Skinovations , Ltd.

K152087HeatLux Pro II K171433Silk'n Infinity K162784Silk'n HST K180279Silk'n MODEL H5003 device DEN190039ToothWave™

Related Devices (Code: QMJ)

DEN190039ToothWave™Home Skinovations , Ltd.

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.

↑