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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K181230
Device Name 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
Applicant
Largan Medical Co., Ltd.
2f., # 14, 23rd Rd., Taichung Industrial Park,
Nantun Dist.
Taichung,  TW 40850
Applicant Contact Amy Tien
Correspondent
Largan Medical Co., Ltd.
2f., # 14, 23rd Rd., Taichung Industrial Park,
Nantun Dist.
Taichung,  TW 40850
Correspondent Contact Amy Tien
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received05/09/2018
Decision Date 06/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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