# Laseroptek Co., Ltd.

- Location (FDA's records): Seongnam-Si, KR
- FDA decisions: 13 (2009–2025): 13 510(k) clearances
- Product codes: GEX (13)
- 510(k) review time since 2016: median 114 days, against 90 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 23 (9 its own); citations of its devices by later devices: 11 (9 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
- Fotona D.D.: 3 (https://510kreport.com/company/fotona-dd)
- Syneron Candela Corporation: 2 (https://510kreport.com/company/syneron-candela)
- Continuum Electro-Optics, Inc.: 2 (https://510kreport.com/company/continuum-electro-optics)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- SNJ Co., Ltd.: 1 (https://510kreport.com/company/snj)
- Photo Medex, Inc.: 1 (https://510kreport.com/company/photo-medex)
- Ra Medical Systems,Inc: 1 (https://510kreport.com/company/ra-medical-systems)
- Asclepion-Meditec AG: 1 (https://510kreport.com/company/asclepion-meditec)

## Firms that cite its devices most
- El.En S.P.A.: 1 (https://510kreport.com/company/el-en)
- Daeju Meditech Engineering Co., Ltd.: 1 (https://510kreport.com/company/daeju-meditech-engineering)

## Its most-cited devices
- K152856: Helios III (2016), cited by 2
- K230373: HELIOS 785 Pico (2023), cited by 2
- K203491: PicoLO Nd: YAG Picosecond Laser System (2021), cited by 1
- K183392: PicoLO Nd:YAG Picosecond Laser System (2019), cited by 1
- K191501: PALLAS 308/311 Solid-State UV Laser System (2020), cited by 1
- K172639: PALLAS 308/311 Solid-State UV Laser System (2017), cited by 1

## Recent decisions
- K243780: HELIOS 785 Pico (1754V2) (Feb 7, 2025)
- K230373: HELIOS 785 Pico (May 22, 2023)
- K223588: PALLAS Premium (Jan 26, 2023)
- K212663: Helios IV 785 (Jun 9, 2022)
- K212573: PicoLO Premium (Dec 8, 2021)
- K203491: PicoLO Nd: YAG Picosecond Laser System (Apr 7, 2021)
- K191501: PALLAS 308/311 Solid-State UV Laser System (Jan 3, 2020)
- K183392: PicoLO Nd:YAG Picosecond Laser System (Jan 4, 2019)

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