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FDA 510(k)

AGNES

K-Number: K160469 · 2017-01-05

ApplicantGowoonsesang Cosmetics Co., Ltd.
Decision Date2017-01-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AGNES is a medical device manufactured by Gowoonsesang Cosmetics Co., Ltd.. It received FDA 510(k) clearance on 2017-01-05 under approval number K160469. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGNES?

AGNES is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Gowoonsesang Cosmetics Co., Ltd.. The 510(k) number is K160469.

When was AGNES approved by the FDA?

AGNES received FDA 510(k) clearance on 2017-01-05, under approval number K160469.

What company makes AGNES?

AGNES is manufactured by Gowoonsesang Cosmetics Co., Ltd..

What is the FDA product code for AGNES?

The FDA product code for AGNES is GEI.

Other Devices by Gowoonsesang Cosmetics Co., Ltd.

K171707GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A

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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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