FDA 510(k) Application Details - K133019

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K133019
Device Name	Laser, Ophthalmic
Applicant	EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM BEBEK YOLU SOKAGI 23/3 ETILER ISTANBUL 34337 TR Other 510(k) Applications for this Company
Contact	MEHMET MELEK 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	09/26/2013
Decision Date	02/20/2015
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