510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K214078Substantially Equivalent

Silk’n Toothwave

Home Skinovations, Ltd., Yokneam, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K214078 is the FDA 510(k) clearance record for Silk’n Toothwave, a class II device, cleared for Home Skinovations , Ltd. on under FDA product code QMJ (Powered Radiofrequency Toothbrush). FDA's definition for product code QMJ reads: "A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and...". FDA records list 15 510(k) clearances for Home Skinovations , Ltd., from to . As of , FDA records show no recalls naming K214078.

Clearance record

Decision date
Received
(382 days to decision)
Product code
QMJ Powered Radiofrequency Toothbrush
Regulation
21 CFR 872.6866
Device class
Class II
Review panel
Dental
Applicant
Home Skinovations , Ltd. Tabor Bldg., Shaar Yokneam, Yokneam, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QMJ

Trailing 12 months

FDA records hold no clearances under product code QMJ in the trailing twelve months.

FDA records show no clearances under product code QMJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QMJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260