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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 the device name listed in this FDA 510(k) record. The listed applicant is Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2017-03-25 under 510(k) 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. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K162784.

When did Silk'n HST receive FDA 510(k) clearance?

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

Who is the listed applicant for Silk'n HST?

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 HST?

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

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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Related Devices (Code: OHS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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