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 K262349
Device Name Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)
Applicant
Risu Medical Technology Co., Ltd.
Rm.201, Bldg. 11, Western Cloud Valley(Phase Iil), The Inter
Fengxi New City Of Xixian New Area
Xian,  CN 712000
Applicant Contact Fuyan Yang
Correspondent
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Rm. 901, Huafa Center, 889 Pinglu Rd., Jing 'An District
Shanghai,  CN 200040
Correspondent Contact Owen He
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/10/2026
Decision Date 10/27/2026
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
-
-