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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K170067
Device Name Easyret
Applicant
Quantel Medical
11 Rue Bois Joli, Cs40015
Cournon D'Auvergne-Cedex,  FR 63808
Applicant Contact Bruno Pages
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number886.4390
Classification Product Code
HQF  
Date Received01/09/2017
Decision Date 07/25/2017
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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