Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Powered Laser Surgical Instrument
510(k) Number K253828
Device Name Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
Applicant
Beijing HuaCheng Taike Technology Co., Ltd.
Rm. 402, 4th Floor, Bldg. 4, Ct.yard 5
South Third St., Huoxian Town, Tongzhou District
Beijing,  CN 101113
Applicant Contact Wang Peng
Correspondent
Tianjin Xinnuocheng Medical Technology Co., LTD.
Rm. 1505, Wanhai Bldg., Dazhigu Sub-District
Hedong District
Tianjin,  CN 300170
Correspondent Contact Lena Zhang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/01/2025
Decision Date 02/27/2026
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
-
-