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 Fo

Lenses, Soft Contact, Daily Wear

Largan Medical Co., Ltd.

The following data is part of a premarket notification filed by Largan Medical Co., Ltd. with the FDA for 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 Fo.

Pre-market Notification Details

Device IDK202129
510k NumberK202129
Device Name: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 Fo
ClassificationLenses, Soft Contact, Daily Wear
Applicant Largan Medical Co., Ltd. 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung,  TW 40850
ContactAmy Tien
CorrespondentAmy Tien
Largan Medical Co., Ltd. 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung,  TW 40850
Product CodeLPL  
CFR Regulation Number886.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2021-04-01

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