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FDA 510(k)

SILK'N FX

K-Number: K110301 · 2011-08-19

ApplicantHome Skinovations , Ltd.
Decision Date2011-08-19
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILK'N FX 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 2011-08-19 under 510(k) number K110301. 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 FX?

SILK'N FX is a medical device that received FDA 510(k) clearance on 2011-08-19. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K110301.

When did SILK'N FX receive FDA 510(k) clearance?

SILK'N FX received FDA 510(k) clearance on 2011-08-19, under 510(k) number K110301.

Who is the listed applicant for SILK'N FX?

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 FX?

The FDA product code for SILK'N FX is OHS.

Other records listing Home Skinovations , Ltd. as applicant

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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.

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