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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 K183647
Device Name SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
Applicant
Olympus Surgical Technologies America
136 Tpke. Rd.
Southborough,  MA  01772
Applicant Contact Jon Gilbert
Correspondent
Olympus Surgical Technologies America
136 Tpke. Rd.
Southborough,  MA  01772
Correspondent Contact Jon Gilbert
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/26/2018
Decision Date 08/09/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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