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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
510(k) Number K221188
Device Name ZEPTO Precision Capsulotomy System
Applicant
Centricity Vision, Inc.
1939 Palomar Oaks Way, Suite A
Carlsbad,  CA  92011
Applicant Contact Neal Hartman
Correspondent
Centricity Vision, Inc.
1939 Palomar Oaks Way, Suite A
Carlsbad,  CA  92011
Correspondent Contact Neal Hartman
Regulation Number886.4100
Classification Product Code
PUL  
Date Received04/25/2022
Decision Date 06/23/2022
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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