FDA.reportPublic FDA data

Led Light Phototherapy Bed

Primary DI
06973337180025
Brand
Led Light Phototherapy Bed
Company
Shenzhen Suyzeko Limited
Model
Pro450
Published
2026-05-09
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
ILYLamp, Infrared, Therapeutic Heating
OLIFat Reducing Low Level Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
OLIFat Reducing Low Level LaserGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252786000Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.2025-12-01OLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973337180025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973337180025069733371800256973337180025

GMDN Terms#

Term, Definition table
TermDefinition
Red/infrared light phototherapy unitAn electrically-powered device designed to emit red light and infrared/near-infrared light for phototherapy primarily to accelerate healing of cutaneous/mucosal tissues and/or to treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood flow. It may have various designs (e.g., hand-held, arched bar, flexible pad for adapting to body areas) and is intended for use in the home and clinical settings.

Regulatory Flags#

DUNS number
551021000
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973337180018Led Light Phototherapy BedGY-680A 2026-05-09
06973337184504Led Light Phototherapy BedPro4502024-07-31
06973337186805Led Light Phototherapy BedGY-680A2024-07-31

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