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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 K110434
Device Name TRIXEL CO2 LASER
Applicant
BEIJING SYNTECH LASER CO., LTD.
P.O. Box 237-023
Shanghai,  CN 200237
Applicant Contact Diana Hong
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/15/2011
Decision Date 04/19/2011
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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