R2GATE Lite TM
K-Number: K223909 · 2023-10-20
ApplicantMegagen Implant Co., Ltd.
Decision Date2023-10-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
R2GATE Lite TM is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-10-20 under approval number K223909. 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 R2GATE Lite TM?
R2GATE Lite TM is a medical device that received FDA 510(k) clearance on 2023-10-20. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K223909.
When was R2GATE Lite TM approved by the FDA?
R2GATE Lite TM received FDA 510(k) clearance on 2023-10-20, under approval number K223909.
What company makes R2GATE Lite TM?
R2GATE Lite TM is manufactured by Megagen Implant Co., Ltd..
What is the FDA product code for R2GATE Lite TM?
The FDA product code for R2GATE Lite TM is LLZ.
Other Devices by Megagen Implant 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.