INTRAcel RF Microneedle System
K-Number: K183284 · 2020-01-15
ApplicantJeisys Medical, Inc.
Decision Date2020-01-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
INTRAcel RF Microneedle System is a medical device manufactured by Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2020-01-15 under approval number K183284. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the INTRAcel RF Microneedle System?
INTRAcel RF Microneedle System is a medical device that received FDA 510(k) clearance on 2020-01-15. It is manufactured by Jeisys Medical, Inc.. The 510(k) number is K183284.
When was INTRAcel RF Microneedle System approved by the FDA?
INTRAcel RF Microneedle System received FDA 510(k) clearance on 2020-01-15, under approval number K183284.
What company makes INTRAcel RF Microneedle System?
INTRAcel RF Microneedle System is manufactured by Jeisys Medical, Inc..
What is the FDA product code for INTRAcel RF Microneedle System?
The FDA product code for INTRAcel RF Microneedle System is GEI.
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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.