Valeda Light Delivery System

Primary DI
B749200002010
Brand
Valeda Light Delivery System
Company
LUMITHERA, INC.
Model
200002-01
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SDELight Based Device For Dry Age-Related Macular Degeneration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SDELight Based Device For Dry Age-Related Macular DegenerationOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230083000Valeda Light Delivery SystemLumithera, Inc.2024-11-04SDE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B749200002010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

Regulatory Flags#

DUNS number
030100076
Device count
1
Serial number
true
Manufacturing date on label
true