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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K082891
FOIA Releasable 510(k) K082891
Device Name LENSTAR, MODEL LS900
Applicant
HAAG-STREIT AG
1667 RIDGEWOOD ROAD
WADSWORTH,  OH  44281
Applicant Contact LENA SATTLER
Correspondent
HAAG-STREIT AG
1667 RIDGEWOOD ROAD
WADSWORTH,  OH  44281
Correspondent Contact LENA SATTLER
Regulation Number886.1850
Classification Product Code
HJO  
Date Received09/30/2008
Decision Date 10/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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