FDA 510(k) Application Details - K223397

Device Classification Name	Lenses, Soft Contact, Daily Wear   More FDA Info for this Device
510(K) Number	K223397
Device Name	Lenses, Soft Contact, Daily Wear
Applicant	HOYA Lamphun Ltd. HOYA Eye Care Thailand Factory, 75/2 Moo 4, Tambol Banklang, Amphur Muang 51000 TH Other 510(k) Applications for this Company
Contact	Timothy Ting 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	11/08/2022
Decision Date	01/03/2024
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