FDA.reportPublic FDA data

Solius

Primary DI
00860014704215
Brand
Solius
Company
Solius Labs, Inc.
Model
Solius iOS App
Device description
Solius iOS app
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
SGZUltraviolet Lamp Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGZUltraviolet Lamp ProductsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252960000SOLIUS PRO UVB Light PanelSolius Labs, Inc.2026-01-16SGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860014704215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014704215008600147042158600147042150860014704215

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet phototherapy unit, home-useAn electrically-powered portable device that includes a lamp which emits light in the ultraviolet (UV) band intended to be used in the home to treat dermatological disorders (e.g., psoriasis, dermatitis) and/or to stimulate the production of endogenous vitamin D. It may have various forms (e.g., flat panel, hand-held tool, desktop unit) and is designed to shine UV light directly on the skin.

Regulatory Flags#

DUNS number
037916336
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014704208SoliusSolius ProSOL-001-01-012026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014704208SoliusSolius Labs, Inc.SGZ2026-05-18