# Wontech Co., Ltd.

- Location (FDA's records): 64, Techno 8-Ro, Yuseong-Gu, KR
- FDA decisions: 30 (2017–2025): 30 510(k) clearances
- Names in FDA's records: Wontech Co., Ltd. (28); Wontech (2)
- Product codes: GEX (22), OAP (5), GEI (3)
- 510(k) review time since 2016: median 94 days, against 90 for FDA's reviews in the same codes and years (15 of 30 faster)
- Predicates its devices cite: 42 (16 its own); citations of its devices by later devices: 28 (16 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
- Cutera, Inc.: 3 (https://510kreport.com/company/cutera)
- Lutronic Corporation: 3 (https://510kreport.com/company/lutronic)
- Candela Corp.: 2 (https://510kreport.com/company/candela)
- Quanta System Spa: 2 (https://510kreport.com/company/quanta-system)
- Hironic Co., Ltd.: 2 (https://510kreport.com/company/hironic)
- Cynosure, Inc.: 2 (https://510kreport.com/company/cynosure)
- Trimedyne, Inc.: 1 (https://510kreport.com/company/trimedyne)
- Syneron Candela Corporation: 1 (https://510kreport.com/company/syneron-candela)

## Firms that cite its devices most
- Beijing HuaCheng Taike Technology Co., Ltd.: 2 (https://510kreport.com/company/beijing-huacheng-taike-technology)
- Shanghai Apolo Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- Ami, Inc.: 1 (https://510kreport.com/company/ami)
- Zhengzhou PZ Laser Slim Technology Co., Ltd.: 1 (https://510kreport.com/company/zhengzhou-pz-laser-slim-technology)
- Ids, Ltd.: 1 (https://510kreport.com/company/ids)
- Nanjing Bestview Laser S&T Co., Ltd.: 1 (https://510kreport.com/company/nanjing-bestview-laser-s-t)
- Jeisys Medical, Inc.: 1 (https://510kreport.com/company/jeisys-medical)
- Speclipse, Inc.: 1 (https://510kreport.com/company/speclipse)

## Its most-cited devices
- K212127: Picocaremajesty (2022), cited by 3
- K241527: Pastelle Pro (2025), cited by 3
- K181272: Picocare Family (2018), cited by 2
- K200110: SANDRO Dual (2020), cited by 2
- K234104: PICOANDY (Q-Switched Nd:YAG Laser) (2024), cited by 2
- K223727: Lavieen (2023), cited by 2

## Recent decisions
- K252877: SANDRO Dual (Dec 19, 2025)
- K250165: Pastelle (Jul 3, 2025)
- K251288: Veincare (May 14, 2025)
- K251094: Alma Veil (May 6, 2025)
- K243957: Picoalex (Mar 12, 2025)
- K241643: WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) (Feb 14, 2025)
- K241527: Pastelle Pro (Feb 14, 2025)
- K243929: Oligio X (Jan 21, 2025)

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