# Jeisys Medical, Inc.

- Location (FDA's records): Seoul, KR
- FDA decisions: 19 (2008–2026): 19 510(k) clearances
- Names in FDA's records: Jeisys Medical, Inc. (15); Jeisys Medical Incorporated (4)
- Product codes: GEI (9), GEX (6), ONF (1), ILY (1), OUH (1), OHV (1)
- 510(k) review time since 2016: median 179 days, against 113 for FDA's reviews in the same codes and years (2 of 13 faster)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 25 (10 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
- Solta Medical, Inc.: 1 (https://510kreport.com/company/solta-medical)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Thermage, Inc.: 1 (https://510kreport.com/company/thermage)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)
- Medicis Technologies Corporation: 1 (https://510kreport.com/company/medicis-technologies)
- Inmode MD, Ltd.: 1 (https://510kreport.com/company/inmode-md)
- Wontech Co., Ltd.: 1 (https://510kreport.com/company/wontech)
- Jm System Co., Ltd.: 1 (https://510kreport.com/company/jm-system)

## Firms that cite its devices most
- VIOL Co., Ltd.: 1 (https://510kreport.com/company/viol)
- Cellah Medical Co., Ltd.: 1 (https://510kreport.com/company/cellah-medical)
- ShenB Co., Ltd.: 1 (https://510kreport.com/company/shenb)
- Gowoonsesang Cosmetics Co., Ltd.: 1 (https://510kreport.com/company/gowoonsesang-cosmetics)
- Cpmt Laser (Canadian Pioneer Medical Technology Corporation): 1 (https://510kreport.com/company/cpmt-laser-canadian-pioneer-medical-technology)
- Skingrab Co., Ltd.: 1 (https://510kreport.com/company/skingrab)
- Shanghai Apolo Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- Nanjing Bestview Laser S&T Co., Ltd.: 1 (https://510kreport.com/company/nanjing-bestview-laser-s-t)

## Its most-cited devices
- K192545: Potenza (2020), cited by 6
- K201685: Potenza (2021), cited by 4
- K153727: INTRAcel Premium Fractional RF Micro Needle (FRM) System (2016), cited by 3
- K162169: EdgeOne CO2 Laser (2016), cited by 3
- K230663: Density (2023), cited by 2
- K231216: Potenza (2024), cited by 2

## Recent decisions
- K254185: Potenza Prime (Sep 11, 2026)
- K251464: TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) (Oct 3, 2025)
- K250065: DENSITY; DENZA; DENSITY Noir (Jul 8, 2025)
- K231216: Potenza (Dec 10, 2024)
- K231287: Potenza (Nov 5, 2024)
- K230663: Density (Aug 14, 2023)
- K223685: SmoothCool HR System (Jan 4, 2023)
- K213484: SmoothCool HR System (Apr 20, 2022)

Source page: https://510kreport.com/company/jeisys-medical