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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Guide, Intraocular
510(k) Number K152357
Device Name MicroSTAAR Injector System Cartridges
Applicant
STAAR Surgical Company
1911 Walker Ave.
Monrovia,  CA  91016
Applicant Contact Jack Coggan
Correspondent
STAAR Surgical Company
1911 Walker Ave.
Monrovia,  CA  91016
Correspondent Contact Jack Coggan
Regulation Number886.4300
Classification Product Code
KYB  
Subsequent Product Code
MSS  
Date Received08/20/2015
Decision Date 10/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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