308nm Excimer System
K-Number: K200971 · 2020-12-15
Decision Date2020-12-15
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
308nm Excimer System is a medical device manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under approval number K200971. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 308nm Excimer System?
308nm Excimer System is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K200971.
When was 308nm Excimer System approved by the FDA?
308nm Excimer System received FDA 510(k) clearance on 2020-12-15, under approval number K200971.
What company makes 308nm Excimer System?
308nm Excimer System is manufactured by Xuzhou Kernel Medical Equipment Co., Ltd..
What is the FDA product code for 308nm Excimer System?
The FDA product code for 308nm Excimer System is FTC.
Related Clinical Trials
Other Devices by Xuzhou Kernel Medical Equipment Co., Ltd.
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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.