510(k) K252960
- Device
- SOLIUS PRO UVB Light Panel
- Applicant
- Solius Labs, Inc.
- 510(k) number
- K252960
- Product code
- SGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-16
- Date received
- 2025-09-16
- Regulation
- 878.4635
- Classification name
- Ultraviolet Lamp Products
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Chris Kiple
- Address
- 100 Ravine Ln. Suite 310 Bainbridge Island WA US 98110 98110
FDA Registration Numbers
- 3008491409