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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 K201268
Device Name Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Applicant
Plexus Optix, Inc.
3333 Quality Dr.
Rancho Cordova,  CA  95670
Applicant Contact Dave Delle Donne
Correspondent
Pegavision Corporation
2f-1, #5, Shing Yeh St., Guishan Dist.
Taoyuan City,  TW 33341
Correspondent Contact Estela Lin
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received05/12/2020
Decision Date 10/21/2020
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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