FDA 510(k)

INTRAcel Premium フラクショナルRFマイクロニードル（FRM）システム

K番号: K153727 · 2016-07-21

決定日2016-07-21

製品コードGEI

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

INTRAcel Premium Fractional RF Micro Needle (FRM) 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 2016-07-21 under 510(k) number K153727. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K153727.

When did INTRAcel Premium Fractional RF Micro Needle (FRM) System receive FDA 510(k) clearance?

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

Who is the listed applicant for INTRAcel Premium Fractional RF Micro Needle (FRM) 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 Premium Fractional RF Micro Needle (FRM) System?

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

申請者としてJeisys Medical, Inc.を記載するその他の記録

K231216ポテンザ K231287ポテンザ K230663デンシティ K223685スムーズクールHRシステム K213484スムーズクールHRシステム K201685ポテンザ

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