FDA 510(k) Application Details - K181232

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K181232
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	Largan Medical Co. Ltd. 2F, No 14, 23rd RD. Taichung Industrial Park, Nantun Dist. Taichung 40850 TW Other 510(k) Applications for this Company
Contact	Amy Tien Other 510(k) Applications for this Contact
Regulation Number	886.5925   More FDA Info for this Regulation Number
Classification Product Code	LPL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2018
Decision Date	06/29/2018
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