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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 With Microbeam\Fractional Output
510(k) Number K221770
Device Name Fiber Laser Treatment System
Applicant
Shanghai Apolo Medical Technology Co., Ltd.
Shanghai,  CN 200231
Applicant Contact Felix Li
Correspondent
Shanghai Apolo Medical Technology Co., Ltd.
Shanghai,  CN 200231
Correspondent Contact Felix Li
Regulation Number878.4810
Classification Product Code
ONG  
Date Received06/21/2022
Decision Date 10/13/2022
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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