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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 K112141
Device Name SMARTEPIL,DEPILASE YAG LASE PLUS
Applicant
Castle Laser Systems, Limited
641 Sshunpike Rd.
Suite 311
Chatham,  NJ  07928
Applicant Contact RAYMOND R BLANCHE
Correspondent
Castle Laser Systems, Limited
641 Sshunpike Rd.
Suite 311
Chatham,  NJ  07928
Correspondent Contact RAYMOND R BLANCHE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/26/2011
Decision Date 04/13/2012
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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