The Valeda Light Delivery System is a prescription, in-office light-based device intended for certain people with dry age-related macular degeneration (AMD). The clinical name for this kind of treatment is photobiomodulation.

FDA De Novo authorization

The FDA granted LumiThera’s De Novo request, number DEN230083, on November 4, 2024. The device is classified as Class II under 21 CFR 886.5520 (product code SDE), as a “light based device for dry age-related macular degeneration.” Records: the De Novo database entry and the decision summary PDF. The FDA described the action as authorized marketing in its November 5, 2024 Roundup.

Indications for use (FDA wording)

The decision summary states the indications for use as follows (quoted):

The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (AMD) characterized by:

• The presence of at least 3 medium drusen (> 63 µm and ≤ 125 µm in diameter), or large drusen (> 125 µm in diameter), or non-central geographic atrophy, AND
• The absence of neovascular maculopathy or center-involving geographic atrophy.

After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.

That last sentence is the authorized description of the average result. Detailed letter-gain tables and geographic-atrophy figures from the LIGHTSITE III papers are collected on the LIGHTSITE III evidence page, where FDA analyses and journal abstracts are kept separate. They are not repeated here as marketing claims.

What this authorization does not mean

• Valeda is not described on this site as a cure, and it is not for everyone with AMD.
• It is not authorized in these indications for wet AMD (neovascular maculopathy) or for center-involving geographic atrophy.
• “Authorized” (De Novo) is not the same wording as a PMA “approval.” We do not say “first and only” in our own voice.
• The FDA summary also notes that treatment benefit may not persist significantly after treatment is stopped, and that safety and effectiveness were not established in several groups excluded from the study (including people under 50, and people with certain other eye conditions). Your doctor will review whether those limits apply to you. See Who it’s for.

Care at Eye Specialists of NEPA

The practice website for Hazleton Eye Specialists states that the five Eye Specialists offices offer Valeda. That is a practice-site statement, not an independent inventory of devices.

An exam comes first. Book from Find an Eye Doctor.

Book an exam

You can choose your office and book an exam online, or call Hazleton Eye Specialists at 570-453-2020.

Sources

• U.S. Food and Drug Administration. DEN230083; decision summary; FDA Roundup, November 5, 2024.
• Practice page (for the “offers Valeda” statement only): Valeda Dry AMD Treatment, drkislan.com.

Medical disclaimer. This page is for general education only. It is not medical advice and does not replace an examination or a conversation with your own doctors. Do not start, stop, or change any medicine or treatment without talking to the clinician who cares for you. If you notice new wavy lines, a sudden blur, or a blank spot in your central vision, seek same-day care from an eye doctor or an emergency department.