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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 K211401
Device Name SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Applicant
Gyrus Acmi, Inc.
800 W. Park Dr.
Westborough,  MA  01581
Applicant Contact Julie Acker
Correspondent
Gyrus Acmi, Inc.
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Julie Acker
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/06/2021
Decision Date 06/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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