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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 K202221
Device Name VX650
Applicant
Luneau Technology Operations
2 rue Roger Bonnet
Pont-de-l'Arche,  FR 27340
Applicant Contact Yossi Constantinis
Correspondent
Luneau Technology Operations
2 rue Roger Bonnet
Pont-de-l'Arche,  FR 27340
Correspondent Contact Yossi Constantinis
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HKX  
Date Received08/06/2020
Decision Date 01/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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