FDA 510(k) Application Details - K201013

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K201013
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	Optixon Inc. 105/106 ho, 164, Obong-ro, Buk-Gu Daegu 41500 KR Other 510(k) Applications for this Company
Contact	Oh Jeong Ju 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	04/17/2020
Decision Date	09/18/2020
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