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FDA 510(k)

INTRAcel Premium Fractional RF Micro Needle (FRM) System

K-Number: K153727 · 2016-07-21

ApplicantJeisys Medical, Inc.
Decision Date2016-07-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRAcel Premium Fractional RF Micro Needle (FRM) System is a medical device manufactured by Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2016-07-21 under approval number K153727. 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 Premium Fractional RF Micro Needle (FRM) System?

INTRAcel Premium Fractional RF Micro Needle (FRM) System is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Jeisys Medical, Inc.. The 510(k) number is K153727.

When was INTRAcel Premium Fractional RF Micro Needle (FRM) System approved by the FDA?

INTRAcel Premium Fractional RF Micro Needle (FRM) System received FDA 510(k) clearance on 2016-07-21, under approval number K153727.

What company makes INTRAcel Premium Fractional RF Micro Needle (FRM) System?

INTRAcel Premium Fractional RF Micro Needle (FRM) System is manufactured by Jeisys Medical, Inc..

What is the FDA product code for INTRAcel Premium Fractional RF Micro Needle (FRM) System?

The FDA product code for INTRAcel Premium Fractional RF Micro Needle (FRM) 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.

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