INTRAcel Premium Fractional RF Micro Needle (FRM) System— 510(k) K153727

Name: FDA 510(k) clearance K153727
Creator: U.S. Food and Drug Administration
Published: 2016-07-21

Substantially Equivalent

Jeisys Medical, Inc.

FDA 510(k) clearance K153727 for INTRAcel Premium Fractional RF Micro Needle (FRM) System, Substantially Equivalent on 2016-07-21. Applicant: Jeisys Medical, Inc.. Device class: 2.

Clearance details

Applicant: Jeisys Medical, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2015-12-28
Decision date: 2016-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.