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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 K203395
Device Name Platform treatment system
Applicant
Shanghai Apolo Medical Technology Co., Ltd.
Rm. 301-310, Bldg. 11, #388, Yindu Rd., Xuhui
District
Shanghai,  CN 200231
Applicant Contact Felix Li
Correspondent
Shanghai Apolo Medical Technology Co., Ltd.
Rm. 301-310, Bldg. 11, #388, Yindu Rd., Xuhui
District
Shanghai,  CN 200231
Correspondent Contact Felix Li
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/18/2020
Decision Date 01/28/2022
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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