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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 K193478
Device Name XTRAC Momentum Excimer Laser System
Applicant
Strata Skin Sciences, Inc.
5 Walnut Grove Dr., Suite 140
Horsham,  PA  19044
Applicant Contact Chuck Mierkiewicz
Correspondent
Strata Skin Sciences, Inc. C/O Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/16/2019
Decision Date 01/14/2020
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
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