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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 K262346
Device Name CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)
Applicant
Wuhan Phomed Technology Co., Ltd.
Rm. 02, 3f, Bldg. 2, Gezhouba Sun City, # 40 Gaoxin 4th Rd.,
Wuhan,  CN 430000
Applicant Contact Xuhua Huang
Correspondent
Wuhan Phomed Technology Co., Ltd.
Rm. 02, 3f, Bldg. 2, Gezhouba Sun City, # 40 Gaoxin 4th Rd.,
Wuhan,  CN 430000
Correspondent Contact Xuhua Huang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/10/2026
Decision Date 10/08/2026
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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