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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 K080591
FOIA Releasable 510(k) K080591
Device Name TANDA SKINCARE SYSTEM, MODEL: PTSCS
Applicant
Pharos Life Corporation
11-380 Jamieson Pkwy.
Cambridge,  CA N3C 4N4
Applicant Contact PHIL CUSCUNA
Correspondent
Pharos Life Corporation
11-380 Jamieson Pkwy.
Cambridge,  CA N3C 4N4
Correspondent Contact PHIL CUSCUNA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/03/2008
Decision Date 11/14/2008
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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