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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2020-01-15 under 510(k) 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. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K183284.

When did INTRAcel RF Microneedle System receive FDA 510(k) clearance?

INTRAcel RF Microneedle System received FDA 510(k) clearance on 2020-01-15, under 510(k) number K183284.

Who is the listed applicant for INTRAcel RF Microneedle System?

The FDA 510(k) record lists Jeisys Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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