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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digital Visual Acuity Test
510(k) Number K220090
Device Name Visibly Digital Acuity Product
Applicant
Visibly, Inc.
207 E Ohio St., #233
Chicago,  IL  60611
Applicant Contact Paul Foley
Correspondent
Hogan Lovells US LLP
1735 Market St.,
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number886.1150
Classification Product Code
QTO  
Date Received01/11/2022
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT05026658
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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