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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Disruption Of Adipocyte Cells For Aesthetic Use
510(k) Number K222265
Device Name Diosculpt
Applicant
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
2f, Bldg. 11, Ln. 1175, Tongpu Rd.
Shanghai,  CN 200333
Applicant Contact Lily Zhou
Correspondent
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
2f, Bldg. 11, Ln. 1175, Tongpu Rd.
Shanghai,  CN 200333
Correspondent Contact Lily Zhou
Regulation Number878.5400
Classification Product Code
PKT  
Date Received07/28/2022
Decision Date 09/23/2022
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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