FDA 510(k) Application Details - DEN230083

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230083
Device Name	Valeda Light Delivery System
Applicant	LumiThera, Inc. 19578 10th Ave. NE Ste 200 Poulsbo, WA 98370 US Other 510(k) Applications for this Company
Contact	Lori Holder Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SDE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2023
Decision Date	11/04/2024
Decision	DENG -
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review