Model: Solius iOS App
DI: 00860014704215
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Solius iOS app
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
307d01b1-6e27-452a-ab4e-b8bf364acd38
Distribution Status:
In Commercial Distribution
DUNS Number:
037916336
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860014704215
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34669
Name: Ultraviolet phototherapy unit, home-use
Definition:
An 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.
FDA Product Codes
SGZ
Ultraviolet Lamp Products
Premarket Submissions
Submission Number:
K252960
Supplement Number:
000