FDA 510(k) Application Details - K124043

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K124043
Device Name	Laser, Ophthalmic
Applicant	LIGHTMED CORP. NO.1-1, LANE1,PAO-AN ST. SEC.3 SHULIN DIST NEW TAIPEI CITY 23861 TW Other 510(k) Applications for this Company
Contact	JOCELYN LIU 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	12/28/2012
Decision Date	09/26/2013
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