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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 K260017
Device Name Picosecond Nd:YAG Laser Systems (Model: HS-298)
Applicant
Shanghai Apolo Medical Technology Co., Ltd.
Bldg. 11, Ln. 1566, Nanle Rd., Songjiang District
Shanghai,  CN 201613
Applicant Contact Felix Li
Correspondent
Shanghai Apolo Medical Technology Co., Ltd.
Bldg. 11, Ln. 1566, Nanle Rd., Songjiang District
Shanghai,  CN 201613
Correspondent Contact Felix Li
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/05/2026
Decision Date 04/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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