# VIOL Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 6 (2017–2026): 6 510(k) clearances
- Product codes: GEI (6)
- 510(k) review time since 2016: median 206 days, against 115 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 5 (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
- Lutronic Corporation: 2 (https://510kreport.com/company/lutronic)
- Jeisys Medical, Inc.: 1 (https://510kreport.com/company/jeisys-medical)
- Cellah Medical Co., Ltd.: 1 (https://510kreport.com/company/cellah-medical)

## Firms that cite its devices most
- Bomtech Electronics Co., Ltd.: 1 (https://510kreport.com/company/bomtech-electronics)

## Its most-cited devices
- K180872: Scarlet SRF (2018), cited by 2
- K172023: Celfirm (2017), cited by 1
- K200185: Sylfirm X (2020), cited by 1
- K213612: Sylfirm X (2022), cited by 1

## Recent decisions
- K253859: Scarlet Pro (Scarlet Pro) (Aug 27, 2026)
- K240897: Cellinew (Nov 26, 2024)
- K213612: Sylfirm X (Jun 23, 2022)
- K200185: Sylfirm X (Apr 22, 2020)
- K180872: Scarlet SRF (Oct 11, 2018)
- K172023: Celfirm (Oct 13, 2017)

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