FDA 510(k) Application Details - K152688

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K152688
Device Name	Laser, Ophthalmic
Applicant	LIGHTMED CORPORATION No. 1-1, Lane 1, Pao-An St., Sec 3, Shulin Dist New Taipei City 23861 TW Other 510(k) Applications for this Company
Contact	Mollie Li 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	09/18/2015
Decision Date	06/15/2016
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