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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, vitreous aspiration and cutting, ac-powered
510(k) Number K170183
Device Name Cetus system, Cetus probe
A.R.C. Laser GmbH
Bessemer St. 14
Nurnberg,  DE 90411
Applicant Contact Angela Thyzel
A.R.C. Laser GmbH
Bessemer St. 14
Nurnberg,  DE 90411
Correspondent Contact Angela Thyzel
Regulation Number886.4150
Classification Product Code
Date Received01/23/2017
Decision Date 09/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No