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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 K102050
Device Name Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
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.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/21/2010
Decision Date 07/29/2010
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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