Silkn Toothwave— 510(k) K214078

Substantially Equivalent

Home Skinovations , Ltd.

FDA 510(k) clearance K214078 for Silkn Toothwave, Substantially Equivalent on 2023-01-13. Applicant: Home Skinovations , Ltd.. Device class: 2.

Clearance details

Applicant: Home Skinovations , Ltd.
Product code: Code QMJ
Device class: Class 2
Regulation: 21 CFR 872.6866
Advisory panel: Dental
Date received: 2021-12-27
Decision date: 2023-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QMJ

DEN190039 — ToothWave2020-09-17

More clearances from Home Skinovations , Ltd.

K180279 — Silk'n MODEL H5003 device2018-05-09
K171433 — Silk'n Infinity2017-08-11
K162784 — Silk'n HST2017-03-25
K152087 — HeatLux Pro II2016-07-29
K150175 — HeatLux Pro I2015-03-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.