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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K163195
Device Name PRIMUS
Applicant
Carl Zeiss Suzhou Co., Ltd.
Modern Industrial Sq. 3b, # 333 Xing Pu Rd. Sip
Suzhou,  CN 215126
Applicant Contact Huang XiaoDong
Correspondent
Carl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin,  CA  94568
Correspondent Contact Dong Hua
Regulation Number886.1570
Classification Product Code
OBO  
Date Received11/15/2016
Decision Date 06/21/2017
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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