FDA 510(k) Application Details - K240095

Device Classification Name	Case, Contact Lens   More FDA Info for this Device
510(K) Number	K240095
Device Name	Case, Contact Lens
Applicant	Shanghai Care Us Medical Product Co., Ltd. No.2, Lane 10, West Chenchuan Road, Baoshan District Shanghai 200949 CN Other 510(k) Applications for this Company
Contact	Charles Shen Other 510(k) Applications for this Contact
Regulation Number	886.5928   More FDA Info for this Regulation Number
Classification Product Code	LRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2024
Decision Date	10/09/2024
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