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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 K251919
Device Name Thulium Laser System (Deluxlase)
Applicant
Nanjing Bestview Laser S&T Co., Ltd.
1st & 2nd Floor, Bldg. 5, Area 1, Phase 2 Liandong U
Vly Science And Tech Innovation Pk, #1 Hengyi Rd.
Nanjing,  CN 210000
Applicant Contact Jing Wang
Correspondent
Nanjing Bestview Laser S&T Co., Ltd.
1st & 2nd Floor, Bldg. 5, Area 1, Phase 2 Liandong U
Vly Science And Tech Innovation Pk, #1 Hengyi Rd.
Nanjing,  CN 210000
Correspondent Contact Jing Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/23/2025
Decision Date 09/26/2025
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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