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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 K253007
Device Name Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
Applicant
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Rm. 208, Bldg. C, # 3, Juquan Rd.
Huangpu District
Guangzhou,  CN 510000
Applicant Contact Zhengzhou Li
Correspondent
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Rm. 208, Bldg. C, # 3, Juquan Rd.
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Zhengzhou Li
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/19/2025
Decision Date 11/20/2025
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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