INTRAcel Premium Fractional RF Micro Needle (FRM) System— 510(k) K153727
Substantially EquivalentJeisys 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
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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More clearances from Jeisys Medical, Inc.
view allAdverse 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, through . 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.