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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photocoagulator And Accessories
510(k) Number K191846
Device Name MAXReach Laser Probe
Applicant
Vortex Surgical, Inc.
680 Crown Industrial Ct. Suite F
Chesterfield,  MO  63005
Applicant Contact Bob Neu
Correspondent
Vortex Surgical, Inc.
680 Crown Industrial Ct. Suite F
Chesterfield,  MO  63005
Correspondent Contact Gary Oliveros
Regulation Number886.4690
Classification Product Code
HQB  
Date Received07/10/2019
Decision Date 12/23/2019
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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