Solius

Primary DI
00860014704222
Brand
Solius
Company
Solius Labs, Inc.
Model
Solius Android App
Device description
Solius Android app
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

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
00860014704222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014704222008600147042228600147042220860014704222

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014704208SoliusSolius ProSOL-001-01-012026-05-18
00860014704215SoliusSolius iOS App2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014704208SoliusSolius Labs, Inc.SGZ2026-05-18
00860014704215SoliusSolius Labs, Inc.SGZ2026-05-05