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FDA 510(k)

COOLSKIN

K-Number: K083008 · 2009-06-10

ApplicantElbio Co., Ltd.
Decision Date2009-06-10
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COOLSKIN is the device name listed in this FDA 510(k) record. The listed applicant is Elbio Co., Ltd.. It received FDA 510(k) clearance on 2009-06-10 under 510(k) number K083008. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOLSKIN?

COOLSKIN is a medical device that received FDA 510(k) clearance on 2009-06-10. The listed applicant is Elbio Co., Ltd.. The 510(k) number is K083008.

When did COOLSKIN receive FDA 510(k) clearance?

COOLSKIN received FDA 510(k) clearance on 2009-06-10, under 510(k) number K083008.

Who is the listed applicant for COOLSKIN?

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

What is the FDA product code for COOLSKIN?

The FDA product code for COOLSKIN is ILO.

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Related Devices (Code: ILO)

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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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