FDA 510(k) Application Details - K230910

Device Classification Name	Lens, Contact (Other Material) - Daily   More FDA Info for this Device
510(K) Number	K230910
Device Name	Lens, Contact (Other Material) - Daily
Applicant	Acculens, Inc. 5353 West Colfax Avenue Lakewood, CO 80214 US Other 510(k) Applications for this Company
Contact	Troy Miller Other 510(k) Applications for this Contact
Regulation Number	886.5916   More FDA Info for this Regulation Number
Classification Product Code	HQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2023
Decision Date	06/16/2023
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