SOLIUS PRO UVB Light Panel
510(k) K252960
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252960 | Date16 Jan 2026 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- SGZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4635
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SOLIUS PRO UVB Light Panel is an ultraviolet lamp product designed for whole-body exposure to UVB radiation. Classified as a Class II device under FDA regulations (878.4635), it is intended for use in stimulating vitamin D production in individuals aged 22 and older. This device delivers controlled UVB light therapy, adhering to safety standards for non-invasive medical applications. Its primary function is to provide a portable, at-home solution for targeted UVB exposure without requiring professional supervision.
The SOLIUS PRO UVB Light Panel is supplied as an over-the-counter (OTC) device and is intended for single-use per session, though the panel itself is reusable. It is not sterile and is not intended for use in sterile environments such as operating rooms or clinical settings. The device is approved under FDA 510(k) clearance (K252960) and is categorized under the product code SGZ for ultraviolet lamp products. No specific MRI safety information is provided, and it is not intended for use in MRI-compatible settings. Storage instructions are not detailed in the specifications, but standard care for UVB devices should be followed.
Other devices from Solius Labs, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the SOLIUS PRO UVB Light Panel used for?
The SOLIUS PRO UVB Light Panel is designed to stimulate vitamin D production in individuals aged 22 and older through controlled whole-body UVB exposure. It provides a portable, at-home solution for targeted UVB therapy without requiring professional supervision, making it suitable for users seeking non-invasive medical light treatment.
Is the SOLIUS PRO UVB Light Panel reusable or single-use?
The SOLIUS PRO UVB Light Panel itself is reusable, meaning the device can be used for multiple sessions. However, each UVB exposure session is intended to be single-use in terms of the light exposure itself, as the device is not designed for continuous operation without breaks.
What are the storage requirements for the SOLIUS PRO UVB Light Panel?
The device does not specify detailed storage instructions, but standard care for UVB devices should be followed. This generally includes storing the panel in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its functionality and safety.
Can the SOLIUS PRO UVB Light Panel be used in sterile environments?
No, the SOLIUS PRO UVB Light Panel is not intended for use in sterile environments such as operating rooms or clinical settings. It is classified as an over-the-counter device and is not sterile, so it should only be used in non-sterile settings like home use.
What regulatory approval does the SOLIUS PRO UVB Light Panel have?
The SOLIUS PRO UVB Light Panel holds FDA 510(k) clearance under the product code SGZ for ultraviolet lamp products. It is classified as a Class II device and was determined to be substantially equivalent to a predicate device through a traditional review process.