# Largan Medical Co., Ltd.

- Location (FDA's records): Taichung, TW
- FDA decisions: 8 (2017–2025): 8 510(k) clearances
- Product codes: LPL (7), MNR (1)
- 510(k) review time since 2016: median 92 days, against 72 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 10 (5 its own); citations of its devices by later devices: 5 (5 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
- CooperVision, Inc.: 3 (https://510kreport.com/company/coopervision)
- Ocular Sciences Puerto Rico, Inc.: 1 (https://510kreport.com/company/ocular-sciences-puerto-rico)
- Clearlab Pte, Ltd.: 1 (https://510kreport.com/company/clearlab)

## Its most-cited devices
- K181232: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (2018), cited by 2
- K182523: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (2018), cited by 2
- K182674: Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (2018), cited by 1

## Recent decisions
- K242916: Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (Feb 4, 2025)
- K233501: “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) (Jul 26, 2024)
- K202129: Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo (Apr 1, 2021)
- K182674: Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (Nov 13, 2018)
- K182523: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (Nov 1, 2018)
- K181232: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (Jun 29, 2018)
- K181230: Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA (Jun 25, 2018)
- K170286: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA (Sep 18, 2017)

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