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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 K252599
Device Name Diode Laser Therapy Systems (WLA-02)
Applicant
Wingderm Electro-Optics , Ltd.
Bldg. 6, # 97 Changping Rd., Shahe Town
Changping District
Beijing,  CN 102206
Applicant Contact Juan Zhou
Correspondent
Suzhou Device Innovation Medical Consulting Co., Ltd.
Rm. 1001, Bldg. 19, # 3188 Renming Rd.
Suzhou,  CN 215000
Correspondent Contact Mike Gu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/18/2025
Decision Date 02/24/2026
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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