SmoothCool HR System— 510(k) K213484

Name: FDA 510(k) clearance K213484
Creator: U.S. Food and Drug Administration
Published: 2022-04-20

Substantially Equivalent

Jeisys Medical, Inc.

FDA 510(k) clearance K213484 for SmoothCool HR System, Substantially Equivalent on 2022-04-20. Applicant: Jeisys Medical, Inc.. Device class: 2.

Clearance details

Applicant: Jeisys Medical, Inc.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-10-29
Decision date: 2022-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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K231216 — POTENZA2024-12-10
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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.