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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 Drive, Suite 140
horsham,  PA  19044
Applicant Contact chuck mierkiewicz
Correspondent
Strata Skin Sciences, Inc. c/o ProMedic, LLC
131 Bay Point 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
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