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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 K182604
Device Name New Era
Applicant
Step UP Skin Laser, LLC
433 Fifth Ave.
6th Floor
New York,  NY  10016
Applicant Contact Michelle Hokama
Correspondent
Law Offices of Irving L. Wiesen, P.C.
420 Lexington Ave.
Suite 2400
New York,  NY  10170
Correspondent Contact Irving Wiesen
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/21/2018
Decision Date 11/14/2018
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
Recalls CDRH Recalls
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