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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K253965
Device Name CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
Applicant
Wuhan PHOMED Technology Company , Ltd.
Rm. 02, 3f, Bldg. 2, Gezhouba Sun City, # 40 Gaoxin
4th Rd., E. Lake New Technology Development Zone
Wuhan,  CN 430200
Applicant Contact Huang Bill
Correspondent
Wuhan PHOMED Technology Company , Ltd.
Rm. 02, 3f, Bldg. 2, Gezhouba Sun City, # 40 Gaoxin
4th Rd., E. Lake New Technology Development Zone
Wuhan,  CN 430200
Correspondent Contact Huang Bill
Regulation Number890.5500
Classification Product Code
ILY  
Subsequent Product Code
PDZ  
Date Received12/11/2025
Decision Date 03/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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