FDA 510(k) Application Details - K150237

Device Classification Name	System, Imaging, Optical Coherence Tomography (Oct)   More FDA Info for this Device
510(K) Number	K150237
Device Name	System, Imaging, Optical Coherence Tomography (Oct)
Applicant	LIGHTLAB IMAGING, INC. 4 ROBBINS ROAD WESTFORD, MA 01886 US Other 510(k) Applications for this Company
Contact	ERDIE DE PERALTA Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	NQQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/02/2015
Decision Date	05/05/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review