FDA 510(k) Application Details - K100019

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K100019
Device Name	Laser, Ophthalmic
Applicant	OPTIMEDICA CORPORATION 155-A MOFFETT PARK DRIVE SUITE 210 SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	DARLENE CROCKETT-BILLING 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	01/05/2010
Decision Date	05/04/2010
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