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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 K261221
Device Name SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Applicant
Olympus Surgical Technologies America
800 W. Park Dr.
Westborough,  MA  01581
Applicant Contact Dolan Mills
Correspondent
Olympus Surgical Technologies America
800 W. Park Dr.
Westborough,  MA  01581
Correspondent Contact Dolan Mills
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/14/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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