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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 K101555
Device Name CO2 LASER SYSTEM
Applicant
Advanced Technology Laser Co., Ltd.
Ln 999, Zhongshan #2 Rd. (S)
Suite 5d, No 19
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/04/2010
Decision Date 09/17/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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