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FDA 510(k)

Silk'n MODEL H5003 device

K-Number: K180279 · 2018-05-09

ApplicantHome Skinovations , Ltd.
Decision Date2018-05-09
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Silk'n MODEL H5003 device 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 2018-05-09 under 510(k) number K180279. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silk'n MODEL H5003 device?

Silk'n MODEL H5003 device is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K180279.

When did Silk'n MODEL H5003 device receive FDA 510(k) clearance?

Silk'n MODEL H5003 device received FDA 510(k) clearance on 2018-05-09, under 510(k) number K180279.

Who is the listed applicant for Silk'n MODEL H5003 device?

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 MODEL H5003 device?

The FDA product code for Silk'n MODEL H5003 device is NGX.

Other records listing Home Skinovations , Ltd. as applicant

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Related Devices (Code: NGX)

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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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