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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K250519
Device Name Lap.Ox™ Laparoscopic Tissue Oximeter
Applicant
ViOptix, Inc.
39655 Eureka Dr.
Newark,  CA  94560
Applicant Contact Scott Coleridge
Correspondent
ViOptix, Inc.
39655 Eureka Dr.
Newark,  CA  94560
Correspondent Contact Mark Lonsinger
Regulation Number870.2700
Classification Product Code
MUD  
Date Received02/21/2025
Decision Date 06/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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