SOLIUS PRO UVB Light Panel
FDA 510(k) clearance K252960 · decided 2026-01-16
Clearance details
- K-number
- K252960
- Device name
- SOLIUS PRO UVB Light Panel
- Applicant
- Solius Labs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-16
- Decision date
- 2026-01-16
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- SGZ
- Device class
- 2
- Regulation number
- 878.4635
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bainbridge Island, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.