Data / Medical devices / United States / Solius Labs, Inc.
Solius Labs, Inc.: FDA-registered device maker in Bainbridge Island, WA, United States, 1 510(k) clearance
Solius Labs, Inc. is registered with the FDA (registration 3018702411) in Bainbridge Island, WA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 16, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018702411
- Address
- 100 Ravine Lane NE Suite 310, Bainbridge Island, WA, United States, 98110
- Owner or operator
- Solius Labs, Inc. (10095354)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 3, 2026
- Registered through
- 2026
- Brand names listed
- Solius Pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ultraviolet Lamp Products | SGZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 16, 2026 | K252960 | SOLIUS PRO UVB Light Panel | SGZ | Substantially Equivalent | Solius Labs, Inc. | accessdata.fda.gov |
Updated January 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.