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FDA 510(k)

rainbow Shine

K-Number: K160079 · 2016-11-10

ApplicantGenoss Co., Ltd.
Decision Date2016-11-10
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

rainbow Shine is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K160079. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the rainbow Shine?

rainbow Shine is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K160079.

When did rainbow Shine receive FDA 510(k) clearance?

rainbow Shine received FDA 510(k) clearance on 2016-11-10, under 510(k) number K160079.

Who is the listed applicant for rainbow Shine?

The FDA 510(k) record lists Genoss Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for rainbow Shine?

The FDA product code for rainbow Shine is EIH.

Other records listing Genoss Co., 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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