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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 K083915
Device Name ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
Applicant
Advanced Technology Laser Co., Ltd.
Ln 999, Zhongshan #2 Rd. (S)
Suite 8d, # 19
Shanghai,  CN 20030
Applicant Contact Diana Hong
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/30/2008
Decision Date 01/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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