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 a medical device manufactured by Rayence Co., Ltd.. It received FDA 510(k) clearance on 2019-03-01 under approval 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. It is manufactured by Rayence Co., Ltd.. The 510(k) number is K183478.
When was ClearON Mobile approved by the FDA?
ClearON Mobile received FDA 510(k) clearance on 2019-03-01, under approval number K183478.
What company makes ClearON Mobile?
ClearON Mobile is manufactured by Rayence Co., Ltd..
What is the FDA product code for ClearON Mobile?
The FDA product code for ClearON Mobile is LLZ.
Other Devices by Rayence Co., Ltd.
Related Devices (Code: LLZ)
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.