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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 K243037
Device Name Diode Laser System model Dawn-S
Applicant
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
2f, Bldg. 11, Lane 1175, Tongpu Rd.,
Shanghai,  CN 200333
Applicant Contact Lily Zhou
Correspondent
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
2f, Bldg. 11, Lane 1175, Tongpu Rd.,
Shanghai,  CN 200333
Correspondent Contact Lily Zhou
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/27/2024
Decision Date 12/26/2024
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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