# Hironic Co., Ltd.

- Location (FDA's records): Yongin-Si, KR
- FDA decisions: 9 (2018–2026): 9 510(k) clearances
- Product codes: GEI (5), GEX (2), PKT (1), NFO (1)
- 510(k) review time since 2016: median 239 days, against 125 for FDA's reviews in the same codes and years (1 of 8 faster)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 9 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Candela Corp.: 2 (https://510kreport.com/company/candela)
- Cutera, Inc.: 1 (https://510kreport.com/company/cutera)
- Ilooda Co,., Ltd.: 1 (https://510kreport.com/company/ilooda)
- Neauvia North America: 1 (https://510kreport.com/company/neauvia-north-america)
- Enraf-Nonius, B.V.: 1 (https://510kreport.com/company/enraf-nonius)
- Bonutti Research, Inc.: 1 (https://510kreport.com/company/bonutti-research)
- Cartessa Aesthetics: 1 (https://510kreport.com/company/cartessa-aesthetics)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)

## Firms that cite its devices most
- Wontech Co., Ltd.: 2 (https://510kreport.com/company/wontech)
- Chungwoo Co., Ltd.: 1 (https://510kreport.com/company/chungwoo)
- Speclipse, Inc.: 1 (https://510kreport.com/company/speclipse)
- Daeju Meditech Engineering Co., Ltd.: 1 (https://510kreport.com/company/daeju-meditech-engineering)

## Its most-cited devices
- K201773: Picohi (2021), cited by 3
- K210084: Silkro (2022), cited by 2
- K241099: Plasonic (Plasonic) (2024), cited by 2
- K173676: A-FIT (2018), cited by 1
- K233123: Silkro (2024), cited by 1

## Recent decisions
- K260387: SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) (Aug 31, 2026)
- K260397: SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) (Apr 6, 2026)
- K251334: New Doublo 2.0 (Sep 29, 2025)
- K241099: Plasonic (Plasonic) (Nov 8, 2024)
- K233123: Silkro (Jun 24, 2024)
- K210084: Silkro (Jun 3, 2022)
- K201773: Picohi (Oct 19, 2021)
- K192970: Slimus (Dec 1, 2020)

Source page: https://510kreport.com/company/hironic