SGZ — Ultraviolet Lamp Products Class II

FDA Device Classification

FDA product code SGZ covers "Ultraviolet Lamp Products", a Class II medical device regulated under 21 CFR 878.4635. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
SGZ
Device Class
Class II
Regulation Number
878.4635
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252960Solius LabsSOLIUS PRO UVB Light PanelJan 16, 2026