510(k) DEN230083
DEN230083 is an FDA 510(k) premarket notification submitted by Lumithera, Inc. for the device "Valeda Light Delivery System". The FDA issued a decision of De Novo Granted on November 4, 2024. The device falls under product code SDE (Light Based Device For Dry Age-Related Macular Degeneration), a Class II device regulated under 21 CFR 886.5520.
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.