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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K251353
Device Name Eyer 2
Applicant
Phelcom Technologies
Rua José Missali, 820, Pq Santa Felícia
São Carlos,  BR 13562-405
Applicant Contact Flávio Pascoal Vieira
Correspondent
Phelcom Technologies
Rua José Missali, 820, Pq Santa Felícia
São Carlos,  BR 13562-405
Correspondent Contact José Roberto Santiciolli Filho
Regulation Number886.1120
Classification Product Code
HKI  
Date Received04/30/2025
Decision Date 01/16/2026
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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