Not Cleared Direct

DEN230083 - Valeda Light Delivery System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230083 · Lumithera, Inc. · Ophthalmic device
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Nov 2024
Decision
326d
Days
Class 2
Risk

DEN230083 is an FDA 510(k) submission (not cleared) for the Valeda Light Delivery System. Classified as Light Based Device For Dry Age-related Macular Degeneration (product code SDE), Class II - Special Controls.

Submitted by Lumithera, Inc. (Poulsbo, US). The FDA issued a Not Cleared (DENG) decision on November 4, 2024 after a review of 326 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5520 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 326 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Lumithera, Inc. devices

Submission Details

510(k) Number DEN230083 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 14, 2023
Decision Date November 04, 2024
Days to Decision 326 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 110d · This submission: 326d
Pathway characteristics

Device Classification

Product Code SDE Light Based Device For Dry Age-related Macular Degeneration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5520
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.