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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 K251772
Device Name Navilas Laser System 577sl (156691)
Applicant
Od-Os GmbH
Warthestr. 21
Teltow,  DE 14513
Applicant Contact Camila Mundt Ilgenfritz
Correspondent
Od-Os GmbH
Warthestr. 21
Teltow,  DE 14513
Correspondent Contact Camila Mundt Ilgenfritz
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/10/2025
Decision Date 10/29/2025
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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