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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Valve
510(k) Number K152996
Device Name Molteno3 Glaucoma Implant
Applicant
Innovative Ophthalmic Products, Inc. (Iop)
3184-B Airway Ave.
Costa Mesa,  CA  92626
Applicant Contact BRYAN WEINMANN
Correspondent
Arent Fox, Llp
1717 K St., NW
Washington,  DC  20006
Correspondent Contact JAMES R RAVITZ
Regulation Number886.3920
Classification Product Code
KYF  
Date Received10/13/2015
Decision Date 12/17/2015
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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