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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 K240118
Device Name Picosecond Nd:YAG Laser System
Applicant
Smedtrum Medical Technology Co., Ltd.
1f., # 8, Ln. 97, Wugong Rd., Xinzhuang Dist.
New Taipei City,  TW 248016
Applicant Contact Crimson Wu
Correspondent
Smedtrum Medical Technology Co., Ltd.
1f., # 8, Ln. 97, Wugong Rd., Xinzhuang Dist.
New Taipei City,  TW 248016
Correspondent Contact Crimson Wu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/16/2024
Decision Date 04/30/2024
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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