VIVA combo RF System (VIVA combo RF System)— 510(k) K234140

Substantially Equivalent

Starmed Co., Ltd.

FDA 510(k) clearance K234140 for VIVA combo RF System (VIVA combo RF System), Substantially Equivalent on 2024-01-30. Applicant: Starmed Co., Ltd..

Clearance details

Applicant: Starmed Co., Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2023-12-29
Decision date: 2024-01-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Goyang-Si, KR

Download summary PDF View on FDA.gov ↗

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.