SILKRO— 510(k) K233123

Name: FDA 510(k) clearance K233123
Creator: U.S. Food and Drug Administration
Published: 2024-06-24

Substantially Equivalent

Hironic Co., Ltd.

FDA 510(k) clearance K233123 for SILKRO, Substantially Equivalent on 2024-06-24. Applicant: Hironic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hironic Co., Ltd.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2023-09-27
Decision date: 2024-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Hironic Co., Ltd.

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K260387 — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)2026-08-31
K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)2026-04-06
K251334 — NEW DOUBLO 2.02025-09-29
K241099 — Plasonic (Plasonic)2024-11-08
K210084 — SILKRO2022-06-03

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.