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 K251464
Device Name TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
Applicant
Jeisys Medical Incorporated
307 Daeryung Techno Town 8th
Gamasan-Ro 96, Geumcheon-Gu
Seoul,  KR 08501
Applicant Contact Jeongwook Lee
Correspondent
E & M
D1474, Pyeongcheon Arco Tower, 230, Simin-Daro, Dongan-Gu
Anyangsi,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/13/2025
Decision Date 10/03/2025
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
-
-