• 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 System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K160878
Device Name OPTIS Metallic Stent Optimization E.4 SW
Applicant
LIGHTLAB IMAGING, INC.
4 ROBBINS ROAD
WESTFORD,  MA  01866
Applicant Contact PADMINI SURAVARAM
Correspondent
LIGHTLAB IMAGING, INC.
4 ROBBINS ROAD
WESTFORD,  MA  01866
Correspondent Contact PADMINI SURAVARAM
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received03/30/2016
Decision Date 06/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-