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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 K213119
Device Name Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Applicant
Innova Vision Inc.
2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park
Hsinchu,  TW 300091
Applicant Contact Kari Huang
Correspondent
Innova Vision Inc.
2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park
Hsinchu,  TW 300091
Correspondent Contact Kari Huang
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received09/27/2021
Decision Date 05/13/2022
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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