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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K162191
Device Name NAVILAS Laser System
Applicant
Od-Os GmbH
14513 Warthestr. 21
Teltow,  DE 14513
Applicant Contact WINFRIED TEIWES
Correspondent
Clinreg Consulting Services, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact JUDY F. GORDON
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
HKI   NFF   NFG  
Date Received08/04/2016
Decision Date 11/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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