510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230083Unknown

Valeda Light Delivery System

Lumithera, Inc., Poulsbo WA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230083 is the FDA 510(k) clearance record for Valeda Light Delivery System, a class II device, cleared for Lumithera, Inc. on under FDA product code SDE (Light Based Device For Dry Age-Related Macular Degeneration). FDA's definition for product code SDE reads: "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...". FDA records list one 510(k) clearance for Lumithera, Inc. As of , FDA records show no recalls naming DEN230083.

Clearance record

Decision date
Received
(326 days to decision)
Product code
SDE Light Based Device For Dry Age-Related Macular Degeneration
Regulation
21 CFR 886.5520
Device class
Class II
Review panel
Ophthalmic
Applicant
Lumithera, Inc. 19578 10th Ave. NE, Poulsbo WA
Third party review
No

Clearances, product code SDE

Trailing 12 months

FDA records hold no clearances under product code SDE in the trailing twelve months.

FDA records show no clearances under product code SDE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SDE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260