Dr. pen Microneedling System
K-Number: K230420 · 2023-08-11
Decision Date2023-08-11
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Dr. pen Microneedling System is a medical device manufactured by Guangzhou Ekai Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-11 under approval number K230420. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dr. pen Microneedling System?
Dr. pen Microneedling System is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Guangzhou Ekai Electronic Technology Co., Ltd.. The 510(k) number is K230420.
When was Dr. pen Microneedling System approved by the FDA?
Dr. pen Microneedling System received FDA 510(k) clearance on 2023-08-11, under approval number K230420.
What company makes Dr. pen Microneedling System?
Dr. pen Microneedling System is manufactured by Guangzhou Ekai Electronic Technology Co., Ltd..
What is the FDA product code for Dr. pen Microneedling System?
The FDA product code for Dr. pen Microneedling System is QAI.
Related Devices (Code: QAI)
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.