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 K252564
Device Name Medical Diode Laser Systems (VeinCure)
Applicant
Baoding Te'Anzhou Electronic Technology Co., Ltd.
Rm. 1702, 17th Floor, Zhibo Technology Comprehensive,
R&D Bldg., # 89, Hengbin Rd.
Baoding,  CN 071000
Applicant Contact Ji chuan Cao
Correspondent
Shenzhen Hlongmed Biotech Co., Ltd.
16th Floor,Tianming Technology Bldg.
#8 Wushitou Rd., N. High-Tech District, Nanshan
Shenzhen,  CN 518000
Correspondent Contact Long Yang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/14/2025
Decision Date 11/07/2025
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
-
-