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 HST

K-Number: K162784 · 2017-03-25

ApplicantHome Skinovations , Ltd.
Decision Date2017-03-25
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Silk'n HST is a medical device manufactured by Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2017-03-25 under approval number K162784. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silk'n HST?

Silk'n HST is a medical device that received FDA 510(k) clearance on 2017-03-25. It is manufactured by Home Skinovations , Ltd.. The 510(k) number is K162784.

When was Silk'n HST approved by the FDA?

Silk'n HST received FDA 510(k) clearance on 2017-03-25, under approval number K162784.

What company makes Silk'n HST?

Silk'n HST is manufactured by Home Skinovations , Ltd..

What is the FDA product code for Silk'n HST?

The FDA product code for Silk'n HST is OHS.

Other Devices by Home Skinovations , Ltd.

K152087HeatLux Pro II K171433Silk'n Infinity K180279Silk'n MODEL H5003 device DEN190039ToothWave™ K214078Silk’n Toothwave

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

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.

↑