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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 K240874
Device Name Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
Applicant
Theralaser Medtech (China) Co., Ltd.
Rm. 407-408, #4 Bldg., Hunan Science And Technology
Industrial Park, Jinzhou N. Rd.lopment Zone
Ingxiang High-Tech Industrial Park Chang,  CN 410600
Applicant Contact Danhong Huang
Correspondent
Theralaser Medtech (China) Co., Ltd.
Rm. 407-408, #4 Bldg., Hunan Science And Technology
Industrial Park, Jinzhou N. Rd.lopment Zone
Ingxiang High-Tech Industrial Park Chang,  CN 410600
Correspondent Contact Danhong Huang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/29/2024
Decision Date 05/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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