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 K261738
Device Name Medical Thulium Fiber Laser Systems (UroFiber 150Q)
Applicant
Rhein Laser Technologies Co., Ltd.
801,8f, E2 Bldg., Future City, #999 High-Tech Ave., E. Lake
Wuhan,  CN 430206
Applicant Contact Na Wu
Correspondent
Rhein Laser Technologies Co., Ltd.
801,8f, E2 Bldg., Future City, #999 High-Tech Ave., E. Lake
Wuhan,  CN 430206
Correspondent Contact Na Wu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/27/2026
Decision Date 07/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-