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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 K180140
Device Name ProFlex Laser Fibers
Applicant
InnovaQuartz LLC
23030 North 15th Ave
Phoenix,  AZ  85027 -1315
Applicant Contact Stephen E Griffin
Correspondent
InnovaQuartz LLC
23030 North 15th Ave
Phoenix,  AZ  85027 -1315
Correspondent Contact Stephen E Griffin
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/18/2018
Decision Date 04/20/2018
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
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