VIVA combo RF System— 510(k) K163450

Name: FDA 510(k) clearance K163450
Creator: U.S. Food and Drug Administration
Published: 2017-03-08

Substantially Equivalent

Starmed Co., Ltd.

FDA 510(k) clearance K163450 for VIVA combo RF System, Substantially Equivalent on 2017-03-08. Applicant: Starmed Co., Ltd.. Device class: 2.

Clearance details

Applicant: Starmed Co., Ltd.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2016-12-08
Decision date: 2017-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

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K233113 — ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L)2023-10-25

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.