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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 K131837
Device Name CO2 FRACTIONAL LASER
Applicant
Beijing Honkon Technologies Co., Ltd.
7th Floor Jinggui Business Bldg. # 982
Congyum Rd., Baiun District
Guangzhou, Guangdong,  CN 510420
Applicant Contact MIKE GU
Correspondent
Beijing Honkon Technologies Co., Ltd.
7th Floor Jinggui Business Bldg. # 982
Congyum Rd., Baiun District
Guangzhou, Guangdong,  CN 510420
Correspondent Contact MIKE GU
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/20/2013
Decision Date 01/22/2014
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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