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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 K233756
Device Name Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
Applicant
Rhein Laser Technologies Co., Ltd.
801,8f, E2building, Future City, #999 High-Tech Ave.
East Lake High-Tech Development Zone
Wuhan,  CN 430206
Applicant Contact Na Wu
Correspondent
Rhein Laser Technologies Co., Ltd.
801,8f, E2building, Future City, #999 High-Tech Ave.
East Lake High-Tech Development Zone
Wuhan,  CN 430206
Correspondent Contact Na Wu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/24/2023
Decision Date 02/02/2024
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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