FDA 510(k) Application Details - K134039

Device Classification Name	Ophthalmoscope,Laser,Scanning   More FDA Info for this Device
510(K) Number	K134039
Device Name	Ophthalmoscope,Laser,Scanning
Applicant	OPTOS PLC 555 13TH STREET, NW WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	RANDY PREBULA Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	MYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2013
Decision Date	04/11/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review