FDA 510(k) Application Details - K142830

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K142830
Device Name	Laser, Ophthalmic
Applicant	OPHTHALMED LLC 1050 Northfield Ct Ste 280 ROSWELL, GA 30076 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2014
Decision Date	06/25/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review