FDA 510(k) Application Details - K232139

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K232139
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	Innova Vision Inc. 2F., No. 20, Prosperity Rd. 1, Hsinchu Science Park Hsinchu 300091 TW Other 510(k) Applications for this Company
Contact	Celine Hsu 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	07/18/2023
Decision Date	11/16/2023
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