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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 K192583
Device Name PicoLazer Laser System
Applicant
Rohrer Aesthetics, LLC
105 Citation Ct.
Birmingham,  AL  35209
Applicant Contact Mark Rohrer
Correspondent
Rohrer Aesthetics, LLC
105 Citation Ct.
Birmingham,  AL  35209
Correspondent Contact Mark Rohrer
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/19/2019
Decision Date 01/17/2020
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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