FDA 510(k) Application Details - K241571

Device Classification Name	Lens, Contact (Other Material) - Daily   More FDA Info for this Device
510(K) Number	K241571
Device Name	Lens, Contact (Other Material) - Daily
Applicant	Boston Foundation for Sight, Inc. d/b/a BostonSight 464 Hillside Ave Suite 205 Needham, MA 02494 US Other 510(k) Applications for this Company
Contact	Sara Yost 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	05/31/2024
Decision Date	08/14/2024
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