• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name powered laser surgical instrument
510(k) Number K073000
Device Name LUMAPROBE
Original Applicant
CLAREBLEND, INC.
675 pine street
elgin,  IL  60123
Original Contact jill creasy
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ILY  
Date Received10/24/2007
Decision Date 10/01/2008
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
-
-