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FDA 510(k)

SILKN BLUE

K-Number: K121435 · 2013-02-22

ApplicantHome Skinovations , Ltd.
Decision Date2013-02-22
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILKN BLUE 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 2013-02-22 under 510(k) number K121435. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILKN BLUE?

SILKN BLUE is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K121435.

When did SILKN BLUE receive FDA 510(k) clearance?

SILKN BLUE received FDA 510(k) clearance on 2013-02-22, under 510(k) number K121435.

Who is the listed applicant for SILKN BLUE?

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 SILKN BLUE?

The FDA product code for SILKN BLUE is OLP.

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Related Devices (Code: OLP)

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

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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