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FDA 510(k)

ClearON Mobile

K-Number: K183478 · 2019-03-01

ApplicantRayence Co., Ltd.
Decision Date2019-03-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearON Mobile is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2019-03-01 under 510(k) number K183478. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearON Mobile?

ClearON Mobile is a medical device that received FDA 510(k) clearance on 2019-03-01. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K183478.

When did ClearON Mobile receive FDA 510(k) clearance?

ClearON Mobile received FDA 510(k) clearance on 2019-03-01, under 510(k) number K183478.

Who is the listed applicant for ClearON Mobile?

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

What is the FDA product code for ClearON Mobile?

The FDA product code for ClearON Mobile is LLZ.

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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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