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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 K153239
Device Name LSFG-NAVI
Applicant
Softcare Co., Ltd.
243-5 Yatsunami
Fukutsu,  JP 811-3201
Applicant Contact Noriyoshi Takahashi
Correspondent
Globizz Corporation
1411 W. 190th St., Suite #200
Gardena,  CA  90248
Correspondent Contact Takahiro Haruyama
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HLI  
Date Received11/09/2015
Decision Date 05/12/2016
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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