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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K183708
Device Name Poly Clear
Applicant
Medtek Skincare, LLC
3 Depot St.
Hudson,  NY  12839
Applicant Contact Gary Richardson
Correspondent
FDA Regulatory Consultants, LLC
1604 NE 4th Ct.
Ft. Lauderdale,  FL  33301
Correspondent Contact Susan Anthony-Dewet
Regulation Number878.4810
Classification Product Code
OLP  
Date Received12/31/2018
Decision Date 09/17/2019
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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