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 K013193
Device Name MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
Applicant
BIOLITEC, INC.
515 SHAKER RD.
EAST LONGMEADOW,  MA  01028
Applicant Contact CAROL J MORELLO
Correspondent
BIOLITEC, INC.
515 SHAKER RD.
EAST LONGMEADOW,  MA  01028
Correspondent Contact CAROL J MORELLO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/24/2001
Decision Date 12/21/2001
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
-
-