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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 K181480
Device Name MMD Tip
Applicant
Strata Skin Sciences, Inc.
100 Lakeside Dr. Suite 100
Horsham,  PA  19044
Applicant Contact Shmuel Gov
Correspondent
Strata Skin Sciences, Inc. % Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/05/2018
Decision Date 08/01/2018
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
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