510(k) DEN230083

Valeda Light Delivery System by Lumithera, Inc. — Product Code SDE

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: November 4, 2024
Date Received: December 14, 2023
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Light Based Device For Dry Age-Related Macular Degeneration
Device Class: Class II
Regulation Number: 886.5520
Review Panel: OP
Submission Type

A light based device for dry age-related macular degeneration is a prescription device intended for use in the application of non- coherent light energy to the eye. The device treats or improves visual acuity in patients with dry age-related macular degeneration.