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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 K221306
Device Name SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
Applicant
Gyrus Acmi, Inc.
800 W Park Dr.
Westborough,  MA  01581
Applicant Contact Jon Gilber
Correspondent
Gyrus Acmi, Inc.
800 W Park Dr.
Westborough,  MA  01581
Correspondent Contact Jon Gilbert
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/05/2022
Decision Date 01/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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