510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252960Substantially Equivalent

SOLIUS PRO UVB Light Panel

Solius Labs, Inc., Bainbridge Island WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252960 is the FDA 510(k) clearance record for SOLIUS PRO UVB Light Panel, a class II device, cleared for Solius Labs, Inc. on under FDA product code SGZ (Ultraviolet Lamp Products). FDA's definition for product code SGZ reads: "An ultraviolet lamp product intended to stimulate the production of Vitamin D". FDA records list one 510(k) clearance for Solius Labs, Inc. As of , FDA records show no recalls naming K252960.

Clearance record

Decision date
Received
(122 days to decision)
Product code
SGZ Ultraviolet Lamp Products
Regulation
21 CFR 878.4635
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Solius Labs, Inc. 100 Ravine Ln., Bainbridge Island WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SGZ

Trailing 12 months
1 clearance under product code SGZ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260