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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K091064
Device Name NAVILAS LASER SYSTEM
Applicant
Od-Os GmbH
733 Bolsana Dr.
Laguna Beach,  CA  92651
Applicant Contact Judy Gordon
Correspondent
Od-Os GmbH
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact Judy Gordon
Regulation Number886.4390
Classification Product Code
HQF  
Date Received04/14/2009
Decision Date 10/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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