DeviceClearance

Product code SGZ— General, Plastic Surgery

SOLIUS PRO UVB Light Panel

Classification name
Ultraviolet Lamp Products
Device class
Class 2
Regulation
21 CFR 878.4635
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“An ultraviolet lamp product intended to stimulate the production of Vitamin D”

— U.S. Food and Drug Administration, device classification record for product code SGZ under 21 CFR 878.4635, via openFDA

Market context for product code SGZ

FDA has cleared 1 device under product code SGZ, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGZ

Recent clearances under product code SGZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.